Tandem Diabetes Care, Inc.
San Diego, CA, US
TANDEM DIABETES CARE, INC. appears in FDA device records in San Diego, CA. FDA records list 26 510(k) clearances between and , 37 PMA records and 5 registered establishments. As of , FDA records show 13 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 26 510(k) clearances for Tandem Diabetes Care, Inc. between 2011 and 2026. The busiest year on record is 2025, with 5. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 1 |
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 1 |
| 2016 | 3 |
| 2019 | 2 |
| 2020 | 3 |
| 2022 | 1 |
| 2023 | 4 |
| 2024 | 2 |
| 2025 | 5 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260429 | Control-IQ+ technology | QJI | Substantially Equivalent | |
| K253074 | Tandem Mobi insulin pump with interoperable technology | QFG | Substantially Equivalent | |
| K250792 | t:slim X2 insulin pump with interoperable technology | QFG | Substantially Equivalent | |
| K251854 | SteadiSet infusion set | FPA | Substantially Equivalent | |
| K250798 | Control-IQ+ technology | QJI | Substantially Equivalent | |
| K243823 | Control-IQ+ technology | QJI | Substantially Equivalent | |
| K241078 | Tandem Mobi Insulin Pump with interoperable technology | QFG | Substantially Equivalent | |
| K240309 | Tandem Mobi insulin pump with interoperable technology | QFG | Substantially Equivalent | |
| K232382 | Control-IQ Technology | QJI | Substantially Equivalent | |
| K232380 | t:slim X2 Insulin Pump with Interoperable Technology | QFG | Substantially Equivalent | |
| K233044 | Tandem Mobi insulin pump with interoperable technology | QFG | Substantially Equivalent | |
| K223213 | Tandem Mobi Insulin Pump with Interoperable Technology | QFG | Substantially Equivalent | |
| K203234 | t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) | QFG | Substantially Equivalent | |
| K200467 | Control-IQ Technology | QJI | Substantially Equivalent | |
| K201214 | t:slim X2 Insulin Pump with Interoperable Technology | QFG | Substantially Equivalent | |
| K193483 | Basal-IQ Technology | QJS | Substantially Equivalent | |
| DEN190034 | Control-IQ Technology | QJI | Unknown | |
| DEN180058 | t:slim X2 insulin pump with interoperable technology | QFG | Unknown | |
| K162080 | t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater | LZG | Substantially Equivalent | |
| K160056 | t:slim Insulin Delivery System | LZG | Substantially Equivalent | |
| K160482 | t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater | LZG | Substantially Equivalent | |
| K143189 | t:flex Insulin Delivery System | LZG | Substantially Equivalent | |
| K141758 | T:SLIM INSULIN DELIVERY SYSTEM | LZG | Substantially Equivalent | |
| K133593 | T:SLIM INSULIN DELIVERY SYSTEM | LZG | Substantially Equivalent | |
| K122361 | T:CONNECT DATA MANAGEMENT SYSTEM | OUG | Substantially Equivalent | |
| K111210 | T:SLIM (TM) INSULIN DELIVERY SYSTEM | LZG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007981285 | 3007981285 | TANDEM DIABETES CARE, INC. | 12400 High Bluff Drive, San Diego, CA 92130 US | 2026 | and 4 more, listed in full below |
| 3016540876 | 3016540876 | TANDEM DIABETES CARE, INC. | 6495 Marindustry Place, San Diego, CA 92121 US | 2026 | |
| 3027327302 | 3027327302 | TANDEM DIABETES CARE, INC. | 2 Wrigley Ste 100, Irvine, CA 92618 US | 2026 | |
| 3032746481 | 3032746481 | TANDEM DIABETES CARE, INC. | 5995 Pacific Center Blvd Ste 104, San Diego, CA 92121 US | 2026 | |
| 3013756811 | 3013756811 | Tandem Diabetes Care, INC. | 10151 Barnes Canyon Road, San Diego, CA 92121 US | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MRZAccessories, Pump, Infusion
- QFGAlternate Controller Enabled Insulin Infusion Pump
- OZOAutomated Insulin Dosing , Threshold Suspend
- NDCCalculator, Drug Dose
- PHVContinuous Glucose Monitor Retrospective Data Analysis Software
- PJTContinuous Glucose Monitor Secondary Display
- PKUInsulin Pump Secondary Display
- QJIInteroperable Automated Glycemic Controller
- QJSInteroperable Automated Glycemic Controller, Insulin Suspend
- OUGMedical Device Data System
- LZGPump, Infusion, Insulin
- OYCPump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
- MDSSensor, Glucose, Invasive
- PQFSensor, Glucose, Invasive, Non-Adjunctive
- FPASet, Administration, Intravascular
- KGXTape And Bandage, Adhesive
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1636-2026 | Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient). | The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when it should instead direct users to confirm that the infusion set is not connected to the body. Following this instruction could result in unintended insulin delivery, potentially leading to a hypoglycemic event. | Class II | Open, Classified | |
| Z-0427-2026 | Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient). Pump, Tandem Mobi, Control-IQ/1010750, Pump, Tandem Mobi, Control-IQ, Replacement/1012719, Pump, Tandem Mobi, Control-IQ 7.6.0.3, Medicare/1013501, Pump, Tandem Mobi, Control-IQ 7.7/1013655, Pump, Tandem Mobi, Control-IQ, 7.7, Replacement/1013656, Pump, Tandem Mobi, Control-IQ 7.7, Medicare/1013700, Pharmacy Kit, Starter Pack, Tandem Mobi 7.7/1014081 | Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. Pump may exhibit false vibration motor failure due to a software issue causing Malfunction 12: "Pump cannot operate, the mobile app can no longer receive data from the pump. Insulin delivery and any active CGM Sessions have been stopped", which could result in hyperglycemia. | Class I | Open, Classified | |
| Z-0232-2026 | t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide when using Dexcom G7 sensor; Tandem Mobi insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014801, 1014811, 1014813, and User Guide when using Dexcom G7 sensor | A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tandem t:slim X2 and version 7.9.0.1 of the Tandem Mobi pump with Control-IQ+ technology that are paired with a G7 sensor may result in an unexpected automatic insulin correction bolus (autobolus ) which could result in hypoglycemia. | Class II | Open, Classified | |
| Z-2343-2025 | Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808; t: slim X2, Basal-IQ, mg/dl, REF: 1004219; Pump, t:slim X2, Clinical Use Only, REF: 1004484; Pump, t:slim X2, Control-IQ, REF: 1005611; Pump, t:slim X2, Control-IQ, mmoUL, Refurbished Replacement, REF: 1005613; Pump, t:slim X2, Control-IQ, mg/dl, REF: 1005615; Pump, t:slim X2, Control-IQ, mg/dl, Refurbished Replacement, REF: 1005617; Pump, t:slim X2, Basal-IQ 6.4, Refurbished Replacement, REF: 1006379; Pump, t:slim X2, Control-IQ 7.4, REF: 1006402; Pump, t:slim X2, Control-IQ 7.4, Replacement, REF: 1006406; Pump, t:slim X2, Control-IQ 7.4, REF: 1006408; Pump, t:slim X2, Basal-IQ, , REF: 1006419; Pump, t:slim X2, Basal-IQ, mg/dL, REF: 1006420; Pump, t:slim X2, Basal-IQ, mmoUL, Refurbished Replacement, REF: 1006535; Pump, t:slim X2, Basal-IQ, mg/dL, Refurbished Replacement, REF: 1006537; Pump, t:slim X2, Control-IQ, mg/dl , Replacement, REF: 1008255; Pump, t:slim X2, Control-IQ, mmoUL, Replacement, REF: 1008256; Pump, t:slim X2, Basal-IQ, mmoUL, Replacement, REF: 1008257; Pump, t:slim X2, Basal-IQ, mg/dl ,Replacement, REF: 1008258; Pump, t:slim X2, Basal-IQ, REF: 1010004; Pump, t:slim X2, Basal-IQ, Replacement, REF: 1010005; Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010006; Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010007; Pump, t:slim X2, Control-IQ, REF: 1010009; Pump, t:slim X2, Control-IQ Replacement, REF: 1010010; Pump, t:slim X2, Control-IQ, Medicare, REF: 1010011; Pump, t:slim X2, Control-IQ, Refurbished Replacement, REF: 1010012; Pump, t:slim X2, Control-IQ, REF: 1012867; Pump, t:slim X2, Control-IQ, Medicare, REF: 1012868; Pump, t:slim X2, Control-IQ, Replacement, REF: 1012869; Pump, t:slim X2, Control-IQ 7.8, REF: 1013195; Pump, t:slim X2, Control-IQ 7.8, Medicare, REF: 1013196; Pump, t :slim X2, Control-IQ 7.8, Replacement, REF: 1013197; Pump, t:slim X2, Control-IQ 7.8, Refurbished Replacement, REF: 1013198 | Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible alerts and causes the pumps to become inoperable and stop infusing insulin which could result in a hyperglycemic event, which may lead to injury and/or hospitalization. | Class I | Open, Classified | |
| Z-2621-2025 | t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app) | an app defect that occurs when the phone is set to a right-to-left language, which causes app-pump pairing issues and graphical defects, which can potentially lead to incorrect therapy decisions and subsequent hypoglycemia or hyperglycemia. | Class II | Open, Classified | |
| Z-1520-2025 | Tandem Mobi Insulin Pump with Interoperable Technology | A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated Glucose Value (EGV) is above 255 mg/dL at the start or end of a gap in data collection due to a lapse in connection from a paired continuous glucose monitor (CGM) sensor, which can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or hyperglycemia. | Class I | Open, Classified | |
| Z-1519-2025 | t:slim X2 Insulin Pump with Interoperable Technology | A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated Glucose Value (EGV) is above 255 mg/dL at the start or end of a gap in data collection due to a lapse in connection from a paired continuous glucose monitor (CGM) sensor, which can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or hyperglycemia. | Class I | Open, Classified | |
| Z-1609-2024 | t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology | During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating system. This cycle intermittently repeats, which leads to excessive Bluetooth communication that may result in pump battery drain and may lead to the pump shutting down sooner than typically expected. Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia, including severe hyperglycemia. | Class I | Open, Classified | |
| Z-1812-2022 | t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump with the Control-IQ Technology | Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate (Fluctuating) Battery Life Display, 3) Touchscreen Staying On, 4) Unexpected Open Loop, that can be mitigated with a software update. Issues could result in hypoglycemia, hyperglycemia or diabetic ketoacidosis. | Class II | Open, Classified | |
| Z-1811-2022 | t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump with the Control-IQ Technology | Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate (Fluctuating) Battery Life Display, 3) Touchscreen Staying On, 4) Unexpected Open Loop, that can be mitigated with a software update. Issues could result in hypoglycemia, hyperglycemia or diabetic ketoacidosis. | Class II | Open, Classified | |
| Z-1258-2022 | t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology | Insulin pumps may display unexpected fluctuation of the remaining battery life so ensure pump battery life does not fall below 25% remaining power. If the battery life drops to less than 5%, insulin delivery will continue for 30 minutes and then the pump will power off and insulin delivery will stop. If the battery reaches 1%, then insulin delivery will stop, which could lead to hyperglycemia. | Class II | Open, Classified | |
| Z-2471-2018 | t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel Gauge, Binary Rev B. | The fuel gauge, the component that reads and reports the battery parameters to the pump, could provide inaccurate readings, which present to the user in one of two ways: A) by triggering a Malfunction 4 Alarm, or B) by triggering a succession of notifications prior to the pump shutting off, including Alert 2 (Battery Low), Alert 3 (Battery Very Low) and Alarm 12 (Battery Very Low). The alarms in both scenarios notify the user that the pump has stopped delivering insulin. | Class II | Open, Classified | |
| Z-0827-2014 | T:slim Insulin Delivery System Insulin Infusion Pump | Specific lots of insulin cartridges that are used with the T:slim Insulin Pump may be at risk for leaking. A cartridge leak could result in the device delivering too much or too little insulin, which can lead to a serious adverse event. | Class I | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain