Dexcom, Inc.
San Diego, CA, US
Dexcom, Inc. appears in FDA device records in San Diego, CA. FDA records list 28 510(k) clearances between and , 134 PMA records and 3 registered establishments. As of , FDA records show 29 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 28 510(k) clearances for Dexcom, Inc. between 2014 and 2026. The busiest year on record is 2026, with 5. The most recent is 2026, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 1 |
| 2015 | 1 |
| 2018 | 3 |
| 2019 | 4 |
| 2020 | 2 |
| 2021 | 2 |
| 2022 | 2 |
| 2023 | 2 |
| 2024 | 3 |
| 2025 | 3 |
| 2026 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K262472 | Stelo Glucose Biosensor System | SBH | Substantially Equivalent | |
| K260935 | Stelo Glucose Biosensor System | SBH | Substantially Equivalent | |
| K261402 | Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System | QBJ | Substantially Equivalent | |
| K261359 | Stelo Glucose Biosensor System | SAF | Substantially Equivalent | |
| K253737 | Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System | QBJ | Substantially Equivalent | |
| K253710 | Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System | QBJ | Substantially Equivalent | |
| K252818 | Dexcom Smart Basal | QRX | Substantially Equivalent | |
| K243214 | Dexcom G7 15 Day Continuous Glucose Monitoring System | QBJ | Substantially Equivalent | |
| K240902 | Dexcom G7 Continuous Glucose Monitoring System | QBJ | Substantially Equivalent | |
| K234070 | Stelo Glucose Biosensor System | SAF | Substantially Equivalent | |
| K234133 | Dexcom G7 Continuous Glucose Monitoring System | QBJ | Substantially Equivalent | |
| K231081 | Dexcom G7 Continuous Glucose Monitoring (CGM) System | QBJ | Substantially Equivalent | |
| K223931 | Dexcom G6 Continuous Glucose Monitoring (CGM) System | QBJ | Substantially Equivalent | |
| K213919 | Dexcom G7 Continuous Glucose Monitoring System | QBJ | Substantially Equivalent | |
| K221259 | Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System | QBJ | Substantially Equivalent | |
| K203089 | Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System | QDK | Substantially Equivalent | |
| K201328 | Dexcom G6 Continuous Glucose Monitoring (CGM) System | QBJ | Substantially Equivalent | |
| K200876 | Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System | QBJ | Substantially Equivalent | |
| K193642 | Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System | QDK | Substantially Equivalent | |
| K192787 | Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System | QDK | Substantially Equivalent | |
| K191833 | Dexcom G6 Pro Continuous Glucose Monitoring System | QII | Substantially Equivalent | |
| K191450 | Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System | QBJ | Substantially Equivalent | |
| K183206 | Dexcom G6 Continuous Glucose Monitoring System | QBJ | Substantially Equivalent | |
| K182405 | Dexcom Pro Q Continuous Glucose Monitoring System | QDL | Substantially Equivalent | |
| K182041 | Dexcom G6 Glucose Program Continuous Glucose Monitoring System | QDK | Substantially Equivalent | |
| DEN170088 | Dexcom G6 Continuous Glucose Monitoring System | QBJ | Unknown | |
| DEN140038 | Dexcom Share Direct Secondary Displays | PJT | Unknown | |
| DEN140016 | STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE | PHV | Unknown |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004753838 | 3004753838 | DEXCOM, INC. | 6340 Sequence Dr, SAN DIEGO, CA 92121 US | 2026 | |
| 3013435121 | 3013435121 | Dexcom, Inc. | 232 South Dobson Road, Mesa, AZ 85202 US | 2026 | |
| 3017425868 | 3017425868 | Dexcom, Inc. | 8046 East Ray Road, Mesa, AZ 85212 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- QRXContinuous Glucose Monitor Informed Insulin Dose Calculator
- PHVContinuous Glucose Monitor Retrospective Data Analysis Software
- PJTContinuous Glucose Monitor Secondary Display
- SBHIntegrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter
- SAFIntegrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter
- QDKIntegrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management
- QIIIntegrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use
- QDLIntegrated Continuous Glucose Monitoring System For Professional Retrospective Use
- QBJIntegrated Continuous Glucose Monitoring System, Factory Calibrated
- MDSSensor, Glucose, Invasive
- PQFSensor, Glucose, Invasive, Non-Adjunctive
- KGXTape And Bandage, Adhesive
Recall records
Showing 25 of 29| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2574-2026 | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail Sensor/Transmitter 1-pack Model/Catalog Number: STP-AT-012 Software Version: N/A Product Description: Dexcom G7 US Retail Sensor/Transmitter 1-pack Component: Dexcom G7 Continuous Glucose Monitoring System | Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by Pharmsource, LLC. Lot 1725204004 were designated for destruction because the G7 sensors were not properly sterilized and have an increased risk of skin infection if used. Lot 1725069002 were designated for destruction due to an increased risk of having no sensor readings available or experiencing sensor inaccuracy that includes the potential for missed detection of a hyperglycemic event or incorrect treatment decisions that can result in patient injury, including medical intervention to prevent permanent injury or impairment. Additionally, due to the unknown storage and handling and storage conditions these sensors may have undergone during the distribution, these sensors may present additional risk. | Class II | Open, Classified | |
| Z-2165-2026 | Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.5.0 and 1.6.0 Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring System | A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information. | Class II | Open, Classified | |
| Z-2164-2026 | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: Versions 2.9.0 through 2.11.2 Product Description: Dexcom G7 CGM watchOS App - The watchOS app is installed along with the iOS phone app and the versions used are the same for each user. The watchOS app cannot be installed independently from the iOS phone app. Component: Dexcom G7 Continuous Glucose Monitoring System, Dexcom G7 15 Day Continuous Glucose Monitoring System | A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information. | Class II | Open, Classified | |
| Z-2163-2026 | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: SW12300 Software Version: Versions 2.9.0 through 2.11.2 Product Description: Dexcom G7 CGM iOS App Component: Dexcom G7 Continuous Glucose Monitoring System, Dexcom G7 15 Day Continuous Glucose Monitoring System | A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information. | Class II | Open, Classified | |
| Z-0318-2026 | Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11678 Software Version: version 1.15.0 Product Description: Dexcom G6 and G6 Pro Android US CGM App SW11678 version 1.15.0 Component: Dexcom G6 Continuous Glucose Monitoring System | A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose values, alarms, alerts or notifications. This could result in the missed detection of a hyperglycemic or hypoglycemic event, protentional resulting in severe hyperglycemia, diabetic ketoacidosis (DKA), or hyperosmolar hyperglycemic state (HHS). | Class I | Open, Classified | |
| Z-2450-2025 | Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.4.0 and earlier Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring System | The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App software (versions 1.4.0 or earlier), henceforth referred to as the App. The affected App does not provide an expected "Sensor Failed" alert when the transmitter sends a "transmitterFailed" error message to the App when the CGM experiences a hardware or firmware failure. Instead, the App ends the CGM sensor session, stops reporting glucose values and displays the Start Sensor screen or No active sensor message without alerting the user, which can lead to missed detection of a hyperglycemic or hypoglycemic event and a delay in treatment. | Class I | Open, Classified | |
| Z-2449-2025 | Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ Android CGM App Model/Catalog Number: SW14245 Software Version: versions 1.4.0 and earlier Product Description: Dexcom ONE+ Androind CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring System | The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App software (versions 1.4.0 or earlier), henceforth referred to as the App. The affected App does not provide an expected "Sensor Failed" alert when the transmitter sends a "transmitterFailed" error message to the App when the CGM experiences a hardware or firmware failure. Instead, the App ends the CGM sensor session, stops reporting glucose values and displays the Start Sensor screen or No active sensor message without alerting the user, which can lead to missed detection of a hyperglycemic or hypoglycemic event and a delay in treatment. | Class I | Open, Classified | |
| Z-2448-2025 | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: versions 2.8.0 and earlier Product Description: Dexcom G7 CGM watchOS App - The watchOS app is installed along with the iOS phone app and the versions used of each are the same for each user. The watchOS app cannot be installed independently from the iOS phone app Component: Dexcom G7 CGM iOS App | The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App software (versions 1.4.0 or earlier), henceforth referred to as the App. The affected App does not provide an expected "Sensor Failed" alert when the transmitter sends a "transmitterFailed" error message to the App when the CGM experiences a hardware or firmware failure. Instead, the App ends the CGM sensor session, stops reporting glucose values and displays the Start Sensor screen or No active sensor message without alerting the user, which can lead to missed detection of a hyperglycemic or hypoglycemic event and a delay in treatment. | Class I | Open, Classified | |
| Z-2447-2025 | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: SW12300 Software Version: version 2.8.0 and earlier Product Description: Dexcom G7 CGM iOS App Component: Dexcom G7 Continuous Glucose Monitoring System | The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App software (versions 1.4.0 or earlier), henceforth referred to as the App. The affected App does not provide an expected "Sensor Failed" alert when the transmitter sends a "transmitterFailed" error message to the App when the CGM experiences a hardware or firmware failure. Instead, the App ends the CGM sensor session, stops reporting glucose values and displays the Start Sensor screen or No active sensor message without alerting the user, which can lead to missed detection of a hyperglycemic or hypoglycemic event and a delay in treatment. | Class I | Open, Classified | |
| Z-2446-2025 | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM Android App Model/Catalog Number: SW12299 Software Version: version 2.8.0 and earlier Product Description: Dexcom G7 CGM Android App SW12299 Component: Dexcom G7 Continuous Glucose Monitoring System | The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App software (versions 1.4.0 or earlier), henceforth referred to as the App. The affected App does not provide an expected "Sensor Failed" alert when the transmitter sends a "transmitterFailed" error message to the App when the CGM experiences a hardware or firmware failure. Instead, the App ends the CGM sensor session, stops reporting glucose values and displays the Start Sensor screen or No active sensor message without alerting the user, which can lead to missed detection of a hyperglycemic or hypoglycemic event and a delay in treatment. | Class I | Open, Classified | |
| Z-1946-2025 | Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 (MT27409-1), STK-DO-013 (MT27409-1), STK-DO-103 (MT27409-2), STK-DO-109 (MT27409-2) | Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death. | Class I | Open, Classified | |
| Z-1945-2025 | Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013 (MT28285-1), STK-D7-014 (MT28285-1), STK-D7-103 (MT28285-2) | Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death. | Class I | Open, Classified | |
| Z-1944-2025 | Dexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-AT-012 (MT26403-0), STK-AT-013 (MT26403-0), STK-GT-001 (MT26403-1), STK-GT-008 (MT26403-5), STK-GT-013 (MT26403-1) , STK-GT-019 (MT26403-4) , STK-GT-100 (MT26403-2), STK-GT-109 (MT26403-2) , STK-GT-113 (MT26403-3) | Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death. | Class I | Open, Classified | |
| Z-1943-2025 | Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1) | Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death. | Class I | Open, Classified | |
| Z-1906-2025 | Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) system | A bug in the 2.7.0 version of the G7 iOS App can cause the app to enter a state where it stops updating the estimated glucose value (EGV) and continues to show this stale EGV. If the user is unaware that the EGVs are not being updated and that glucose alerts will not trigger, there is potential for the missed detection of a hyperglycemic or hypoglycemic event or a treatment decision made based off incorrect data. There is no impact to transmitter communication with concurrently connected displays. A concurrently connected receiver, Apple Watch, and/or insulin pump will continue to receive EGVs directly from the transmitter when the app is in the problematic state. There is no impact to Automated Insulin Dosing (AID) therapy as the AID system continues to receive EGVs directly from the transmitter. | Class II | Open, Classified | |
| Z-1204-2025 | Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OE-001 | Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different conditions. First, if a receiver operating system .net error occurs when an alarm/alert should be triggered, the initial alarm/alert will not be delivered until a subsequent alarm/alert is triggered. At that time, the initial alarm/alert is delivered, but not the second one. Alarm/alerts will continue to be delayed and be one alarm/alert behind, causing delayed alarm/alerts until the receiver is reset. This condition could result in the missed detection of a hyperglycemic or hypoglycemic event. Second, a single EGV reading may be delayed for 5 minutes after the initial .net operating system error. If the user receives a single EGV reading delayed by 5 minutes, the delay is not expected to cause user harm. | Class II | Open, Classified | |
| Z-1203-2025 | Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001 | Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different conditions. First, if a receiver operating system .net error occurs when an alarm/alert should be triggered, the initial alarm/alert will not be delivered until a subsequent alarm/alert is triggered. At that time, the initial alarm/alert is delivered, but not the second one. Alarm/alerts will continue to be delayed and be one alarm/alert behind, causing delayed alarm/alerts until the receiver is reset. This condition could result in the missed detection of a hyperglycemic or hypoglycemic event. Second, a single EGV reading may be delayed for 5 minutes after the initial .net operating system error. If the user receives a single EGV reading delayed by 5 minutes, the delay is not expected to cause user harm. | Class II | Open, Classified | |
| Z-1202-2025 | Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001 | Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different conditions. First, if a receiver operating system .net error occurs when an alarm/alert should be triggered, the initial alarm/alert will not be delivered until a subsequent alarm/alert is triggered. At that time, the initial alarm/alert is delivered, but not the second one. Alarm/alerts will continue to be delayed and be one alarm/alert behind, causing delayed alarm/alerts until the receiver is reset. This condition could result in the missed detection of a hyperglycemic or hypoglycemic event. Second, a single EGV reading may be delayed for 5 minutes after the initial .net operating system error. If the user receives a single EGV reading delayed by 5 minutes, the delay is not expected to cause user harm. | Class II | Open, Classified | |
| Z-1562-2020 | Dexcom G6 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes. | The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Continuous Glucose Monitoring Systems. | Class II | Terminated | |
| Z-1561-2020 | Dexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes. | The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Continuous Glucose Monitoring Systems. | Class II | Terminated | |
| Z-1560-2020 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes. | The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Continuous Glucose Monitoring Systems. | Class II | Terminated | |
| Z-1104-2020 | Brand Name: Dexcom G6 CGM App for iOS Software Number: SW11677 Software Version: Version 1.4.0 up to corrected Version 1.4.4 GUDID Registered GTIN: 00386270000804 | It was reported that the user's low alarm feature on the iOS application were not properly alerting users when the user has enabled the Alert Schedule feature more than 30 days after installing the iOS application. | Class II | Terminated | |
| Z-0929-2020 | Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing software version SW10617 and revision 4.0.1.048 - Product Usage: A non-adjunctive invasive glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions. The device also provides historical glucose information, facilitating long-term therapy adjustments. | It has been reported that use of the mobile receiver with software version SW10617 rev 4.0.1.048 have reported: 1. the receiver becoming stuck on initialization screen when powering on. This will cause patients not to be able to receive glucose values or alerts; 2. Reinitialization of the receiver without user interaction. If this occurs, the receiver will either reboot and operate normally or require the user to press the Select button on the receiver in order to resume normal operation. In this situation, the user is provided an audio and vibratory alert every 5 minutes. Until the select button is pressed, patients will not receive glucose values or alerts. | Class II | Terminated | |
| Z-1339-2016 | Dexcom G5 Mobile Receiver Receiver Part Number: MT22719 Receiver (mg/dL), Black; MT22719-PNK, Receiver (mg/dL), Pink; MT22719-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes. | Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert. | Class I | Terminated | |
| Z-1338-2016 | Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT22608 Receiver (mg/dL), Black (pediatrics); MT22608-PNK, Receiver (mg/dL), Pink (pediatrics); MT22608-BLU, Receiver (mg/dL), Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes. | Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert. | Class I | Terminated |
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