Masimo Corporation
Irvine, CA, US
MASIMO CORPORATION appears in FDA device records in Irvine, CA. FDA records list 115 510(k) clearances between and , no PMA records and 4 registered establishments. As of , FDA records show 16 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 115FDA records hold 115 510(k) clearances for Masimo Corporation between 1997 and 2026. The busiest year on record is 2004, with 9. The most recent is 2026, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 1 |
| 1998 | 1 |
| 1999 | 4 |
| 2000 | 8 |
| 2001 | 4 |
| 2003 | 2 |
| 2004 | 9 |
| 2005 | 6 |
| 2006 | 4 |
| 2007 | 2 |
| 2008 | 4 |
| 2009 | 7 |
| 2010 | 6 |
| 2011 | 5 |
| 2012 | 4 |
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 1 |
| 2016 | 5 |
| 2017 | 3 |
| 2018 | 3 |
| 2019 | 5 |
| 2020 | 5 |
| 2021 | 3 |
| 2022 | 3 |
| 2023 | 8 |
| 2024 | 3 |
| 2025 | 3 |
| 2026 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253417 | Masimo Root Monitoring System | MWI | Substantially Equivalent | |
| K260880 | SedLine Sedation Monitor | OLW | Substantially Equivalent | |
| K254209 | Radius VSM and Accessories | MHX | Substantially Equivalent | |
| K243324 | Masimo O3 Regional Oximeter | MUD | Substantially Equivalent | |
| K250757 | Radius VSM and Accessories | MHX | Substantially Equivalent | |
| K243305 | Masimo W1 | DPS | Substantially Equivalent | |
| K240229 | Masimo W1 | DPS | Substantially Equivalent | |
| K234021 | Masimo Stork | QYU | Substantially Equivalent | |
| K214115 | MightySat -OTC | OLK | Substantially Equivalent | |
| K223721 | Masimo Stork | DQA | Substantially Equivalent | |
| K232512 | Masimo W1 | DPS | Substantially Equivalent | |
| DEN200076 | ORi | QWE | Unknown | |
| K232389 | Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue | DQA | Substantially Equivalent | |
| K223498 | Radius VSM and Accessories | MHX | Substantially Equivalent | |
| K213676 | Masimo Rad-G with Temperature | DQA | Substantially Equivalent | |
| DEN200011 | Masimo SafetyNet | QVT | Unknown | |
| K212161 | Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories | MWI | Substantially Equivalent | |
| K221953 | Masimo CARESCAPE SpO2 – Masimo with SpHb | DQA | Substantially Equivalent | |
| K214072 | Masimo O3 Regional Oximeter System | MUD | Substantially Equivalent | |
| K203113 | Masimo SedLine Sedation Monitor and Accessories | OLW | Substantially Equivalent | |
| K212876 | Carescape SpO2 - Masimo | DQA | Substantially Equivalent | |
| K203215 | Radius T wearable thermometer | FLL | Substantially Equivalent | |
| K201590 | EMMA Capnograph | CCK | Substantially Equivalent | |
| K201770 | Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor | DQA | Substantially Equivalent | |
| K201432 | Masimo O3 Regional Oximeter System | MUD | Substantially Equivalent | |
| K193626 | Masimo Rad-97 Pulse CO-Oximeter and Accessories | MWI | Substantially Equivalent | |
| K191882 | Masimo Centroid System | MWI | Substantially Equivalent | |
| K193242 | Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories | MWI | Substantially Equivalent | |
| K191059 | Masimo Rad-97 and Accessories | MWI | Substantially Equivalent | |
| K182429 | Masimo O3 Regional Oximeter System | MUD | Substantially Equivalent | |
| K183697 | Masimo Rad-97 and Accessories | MWI | Substantially Equivalent | |
| K182887 | Masimo Rad-67 Pulse CO-Oximeter and Accessories | DQA | Substantially Equivalent | |
| K181956 | Masimo MightySat Rx Fingertip Pulse Oximeter | DQA | Substantially Equivalent | |
| K180046 | Masimo Rad-97 and Accessories | DQA | Substantially Equivalent | |
| K173976 | Masimo Acoustic Respiration Sensors, infant and neonate | BZQ | Substantially Equivalent | |
| K172890 | SedLine Sedation Monitor | OLW | Substantially Equivalent | |
| K171121 | Masimo Root Monitoring System and Accessories | MWI | Substantially Equivalent | |
| K170168 | Masimo Rad-97 and Accessories | MWI | Substantially Equivalent | |
| K162603 | Masimo O3 Regional Oximeter System | MUD | Substantially Equivalent | |
| K162675 | Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter | DQA | Substantially Equivalent | |
| K160940 | Masimo Disposable Transflectance Forehead Sensor | DQA | Substantially Equivalent | |
| K153225 | Masimo Root Monitoring System and Accessories | MWI | Substantially Equivalent | |
| K160526 | Masimo O3 Regional Oximeter System | MUD | Substantially Equivalent | |
| K151644 | Masimo Root Vital Signs Monitoring System and Accessories | MWI | Substantially Equivalent | |
| K150314 | Masimo MightySat Rx Fingertip Pulse Oximeter | DQA | Substantially Equivalent | |
| K142394 | Masimo Root Monitoring System and Accesories | MWI | Substantially Equivalent | |
| K140188 | MASIMO ROOT MONITORING SYSTEM | MWI | Substantially Equivalent | |
| K120984 | MASIMO RAS-125C ACOUSTIC RESPIRATION SENSOR | DQA | Substantially Equivalent | |
| K120657 | MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS | DQA | Substantially Equivalent | |
| K121914 | MASIMO SET USPO2 PULSE OXIMETRY CABLE | DQA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009831876 | 3009831876 | MASIMO CORPORATION | 9600 Jeronimo, Irvine, CA 92618 US | 2026 | and 22 more, listed in full below |
| 3011353843 | 3011353843 | MASIMO CORPORATION | 52 Discovery, Irvine, CA 92618 US | 2026 | and 32 more, listed in full below |
| 3013250653 | 3013250653 | MASIMO CORPORATION | 15776 Laguna Canyon Road, Irvine, CA 92618 US | 2026 | |
| 3019388613 | 3019388613 | Masimo Corporation | 15750 Alton Parkway, Irvine, CA 92618 US | 2026 | and 30 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DSJAlarm, Blood-Pressure
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- NHOAnalyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
- CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
- CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
- NHQAnalyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)
- CBRAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- NHPAnalyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
- DXQBlood Pressure Cuff
- ORTBurst Suppression Detection Software For Electroencephalograph
- DSACable, Transducer And Electrode, Patient, (Including Connector)
- CATCannula, Nasal, Oxygen
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function
- DQKComputer, Diagnostic, Programmable
- BZAConnector, Airway (Extension)
- FLLContinuous Measurement Thermometer
- DSIDetector And Alarm, Arrhythmia
- DPSElectrocardiograph
- GXYElectrode, Cutaneous
- GWQFull-Montage Standard Electroencephalograph
- QWEHyperoxia Monitoring Device Adjunct To Pulse Oximetry
- OLWIndex-Generating Electroencephalograph Software
- QYUInfant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use
- OUGMedical Device Data System
- QVTMonitor For Opioid Induced Impairment Of Oxygenation
- KMIMonitor, Bed Patient
- BZQMonitor, Breathing Frequency
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- OLTNon-Normalizing Quantitative Electroencephalograph Software
- DQAOximeter
- DPZOximeter, Ear
- OCHOximeter, Infrared, Sporting, Aviation
- NLFOximeter, Reprocessed
- MUDOximeter, Tissue Saturation
- OLKPulse Oximeter For Over-The-Counter Use
- OMCReduced- Montage Standard Electroencephalograph
- JKSSpectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- MSXSystem, Network And Communication, Physiological Monitors
- DXHTransmitters And Receivers, Electrocardiograph, Telephone
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2671-2026 | Radius VSM Disposable NIBP Cuff, REF: 4825, 4826 | Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness. | Class II | Open, Classified | |
| Z-2670-2026 | Radius VSM ECG pre-connected Set, REF: 4842, 4695 | Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness. | Class II | Open, Classified | |
| Z-1539-2024 | Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only, | Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring. | Class II | Open, Classified | |
| Z-1538-2024 | Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only, | Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring. | Class II | Open, Classified | |
| Z-1537-2024 | Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only, | Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring. | Class II | Open, Classified | |
| Z-1536-2024 | Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only, | Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring. | Class II | Open, Classified | |
| Z-1986-2023 | Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503 | TC-I tip clip sensor may produce readings outside the accuracy specification. | Class II | Open, Classified | |
| Z-1985-2023 | Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895 | TC-I tip clip sensor may produce readings outside the accuracy specification. | Class II | Open, Classified | |
| Z-1984-2023 | Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794 | TC-I tip clip sensor may produce readings outside the accuracy specification. | Class II | Open, Classified | |
| Z-1983-2023 | Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053 | TC-I tip clip sensor may produce readings outside the accuracy specification. | Class II | Open, Classified | |
| Z-0338-2016 | rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW DCI-dc8, SpO2/SpCO/SpMet, Part No. 2407; RAINBOW DCI, SpO2/SpCO/SpMet, Part No. 2696; RAINBOW DCIP, PED, SpO2/SpCO/SpMet, Part No. 2697. rainbow reusable sensors are indicated for spot check or continuous non-invasive monitoring of arterial saturation (SpO2), arterial carboxyhemoglobin saturation (SpCO), arterial methemoglobin (SpMet), and pulse rate. | These sensors were manufactured with incompatible configurations. This could result in sensors that will provide either no readings or inaccurate readings for the SpCO and SpMet parameters. | Class II | Terminated | |
| Z-0213-2015 | Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate when installed in a compatible OEM host system. Shipping/Package: All Pulse Oximetry cables are shipped non-sterile in a cardboard carton. They are intended to be used non-sterile. | Firm has identified a small number of Oximetry Cables with crossed-internal wires. The effect on performance when these wires are crossed is that when a low SpO2 value is measured, a high SpO2 value would be displayed on the monitoring device. Additionally when a high SpO2 value is measured, a low SpO2 value would be displayed on the monitoring device. | Class II | Terminated | |
| Z-1187-2013 | Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). | Masimo has identified a very small number (0.02%) of Rad-8 devices with 20-pin patient cable connector that, when moved, can power off without the operator pressing the power button. | Class II | Terminated | |
| Z-1387-2011 | Masimo Hemoglobin Pronto-7 with Rainbow 40 Technology for easy-to-use spot-check testing of hemoglobin (SpHb), SpO2, pulse rate, and perfusion index Pronto-7 rainbow 4D Reusable Sensors are an accessory to the Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter. The Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter (instrument) with Masimo Rainbow SET Technology is developed to simultaneously and non-invasively measure functional arterial oxygen saturation (SpO2), pulse rate (PR), total hemoglobin (SpHb) and perfusion index (PI). The instrument has a single on/off button and an interactive touchscreen for administering tests along with user selectable options. | Masimo Corporation is initiating a voluntary recall on the Pronto-7 rainbow 4D Resuable Sensor because when performing an SpHb measurement, the sensor may incorrectly read actual finger temperature. As a result, Pronto-7 Check Pulse CO-Oximeter may provide an incorrect SpHb measurement. | Terminated | ||
| Z-0661-06 | Rainbow DC-I-DC Pulse CO-Oximeter Sensor used with the Masimo SET Rad 57 Pulse CoOximeter | Internal testing revealed that some of the sensors might not meet the accuracy specifications of : 2% for SpO2 and of: 3% for SpCO, due to the tolerance of one of the emitter LED's used in the calculation ofSpO2 and SpCO. The SpO2 reading may have a negative bias of up to 1 % and the SpCO reading may have a negative bias of up to 4%. | Terminated | ||
| Z-0933-05 | Radical Handheld Pulse Oximeter | Speaker component failure resulting in ceasation of an audible alarm even though the condition continues that caused the alarm. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain