Masimo Corporation
Medical device manufacturer in Irvine, CA.
113510(k) clearances
0PMA approvals
14recalls
Device types
- DQA Oximeter 77
- MWI Monitor, Physiological, Patient (Without… 13
- MUD Oximeter, Tissue Saturation 6
- OLW Index-Generating Electroencephalograph… 3
- MHX Monitor, Physiological, Patient(With… 3
- DPS Electrocardiograph 3
- NLF Oximeter, Reprocessed 2
- MSX System, Network And Communication… 1
- BZQ Monitor, Breathing Frequency 1
- CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase 1
- FLL Continuous Measurement Thermometer 1
- OLK Pulse Oximeter For Over-The-Counter Use 1
- QYU Infant Pulse Rate And Oxygen Saturation… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K253417 | Masimo Root Monitoring SystemMWI · Traditional | 08/12/2026SE |
| K260880 | SedLine Sedation MonitorOLW · Traditional | 07/10/2026SE |
| K254209 | Radius VSM and AccessoriesMHX · Traditional | 06/04/2026SE |
| K243324 | Masimo O3 Regional OximeterMUD · Traditional | 07/17/2025SE |
| K250757 | Radius VSM and AccessoriesMHX · Traditional | 05/29/2025SE |
| K243305 | Masimo W1DPS · Traditional | 04/03/2025SE |
| K240229 | Masimo W1DPS · Traditional | 08/08/2024SE |
| K234021 | Masimo StorkQYU · Traditional | 05/03/2024SE |
| K214115 | MightySat -OTCOLK · Traditional | 01/31/2024SE |
| K223721 | Masimo StorkDQA · Traditional | 12/15/2023SE |
| K232512 | Masimo W1DPS · Traditional | 11/17/2023SE |
| K232389 | Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueDQA · Special | 09/07/2023SE |
| K223498 | Radius VSM and AccessoriesMHX · Traditional | 06/01/2023SE |
| K213676 | Masimo Rad-G with TemperatureDQA · Traditional | 04/16/2023SE |
| K212161 | Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMWI · Traditional | 03/06/2023SE |
| K221953 | Masimo CARESCAPE SpO2 Masimo with SpHbDQA · Special | 08/04/2022SE |
| K214072 | Masimo O3 Regional Oximeter SystemMUD · Traditional | 05/06/2022SE |
| K203113 | Masimo SedLine Sedation Monitor and AccessoriesOLW · Traditional | 02/25/2022SE |
| K212876 | Carescape SpO2 - MasimoDQA · Special | 10/08/2021SE |
| K203215 | Radius T wearable thermometerFLL · Traditional | 06/11/2021SE |
| K201590 | EMMA CapnographCCK · Special | 03/29/2021SE |
| K201770 | Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorDQA · Special | 09/24/2020SE |
| K201432 | Masimo O3 Regional Oximeter SystemMUD · Traditional | 08/29/2020SE |
| K193626 | Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMWI · Traditional | 08/10/2020SE |
| K191882 | Masimo Centroid SystemMWI · Traditional | 04/22/2020SE |
| K193242 | Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and…MWI · Traditional | 02/27/2020SE |
| K191059 | Masimo Rad-97 and AccessoriesMWI · Traditional | 12/27/2019SE |
| K182429 | Masimo O3 Regional Oximeter SystemMUD · Traditional | 06/07/2019SE |
| K183697 | Masimo Rad-97 and AccessoriesMWI · Traditional | 05/15/2019SE |
| K182887 | Masimo Rad-67 Pulse CO-Oximeter and AccessoriesDQA · Traditional | 03/22/2019SE |
| K181956 | Masimo MightySat Rx Fingertip Pulse OximeterDQA · Traditional | 01/23/2019SE |
| K180046 | Masimo Rad-97 and AccessoriesDQA · Traditional | 10/23/2018SE |
| K173976 | Masimo Acoustic Respiration Sensors, infant and neonateBZQ · Abbreviated | 09/05/2018SE |
| K172890 | SedLine Sedation MonitorOLW · Traditional | 01/26/2018SE |
| K171121 | Masimo Root Monitoring System and AccessoriesMWI · Traditional | 11/17/2017SE |
| K170168 | Masimo Rad-97 and AccessoriesMWI · Traditional | 09/14/2017SE |
| K162603 | Masimo O3 Regional Oximeter SystemMUD · Traditional | 05/26/2017SE |
| K162675 | Masimo Rainbow SET Intellivue Module Pulse CO-OximeterDQA · Traditional | 12/28/2016SE |
| K160940 | Masimo Disposable Transflectance Forehead SensorDQA · Traditional | 11/23/2016SE |
| K153225 | Masimo Root Monitoring System and AccessoriesMWI · Traditional | 06/21/2016SE |
| K160526 | Masimo O3 Regional Oximeter SystemMUD · Traditional | 06/09/2016SE |
| K151644 | Masimo Root Vital Signs Monitoring System and AccessoriesMWI · Traditional | 02/12/2016SE |
| K150314 | Masimo MightySat Rx Fingertip Pulse OximeterDQA · Traditional | 10/22/2015SE |
| K142394 | Masimo Root Monitoring System and AccesoriesMWI · Traditional | 11/25/2014SE |
| K140188 | Masimo Root Monitoring SystemMWI · Traditional | 06/25/2014SE |
| K120984 | Masimo RAS-125C Acoustic Respiration SensorDQA · Traditional | 04/26/2013SE |
| K120657 | Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsDQA · Traditional | 09/19/2012SE |
| K121914 | Masimo Set USPO2 Pulse Oximetry CableDQA · Special | 09/07/2012SE |
| K121912 | E1 Ear SensorsDQA · Special | 07/24/2012SE |
| K113596 | Masimo Set Reusable Oximetry SensorsDQA · Special | 02/24/2012SE |
| K111403 | Masimo Rainbow Set PRONTO-7 Pulse Co-Oximeter and AccessoriesDQA · Traditional | 12/30/2011SE |
| K111621 | Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-Lncs Oximetry SensorsDQA · Traditional | 10/26/2011SE |
| K111888 | Masimo Lnop/Lncs/M-Lncs Multisite-L Oximetry SensorsDQA · Special | 09/23/2011SE |
| K110723 | M-Lncs Oximetry Sensors, Reprocessed M-Lncs Oximetry SensorsNLF · Special | 07/28/2011SE |
| K110028 | Masimo Radical Y Pulse Co-OximeterDQA · Special | 03/17/2011SE |
| K101031 | Masimo Disposable Oximetry Ear Sensor, Model E1DQA · Traditional | 11/18/2010SE |
| K101896 | Masimo Lncs/M-Lncs Oximetry SensorsDQA · Special | 10/21/2010SE |
| K100428 | Masimo Rainbow Set Radical 7R Pulse Co-OximeterDQA · Traditional | 07/09/2010SE |
| K100403 | Masimo Rainbow Set Pronto -7 Pulse Co- Oximeter and Accessories, Model PRONTO-7DQA · Traditional | 06/23/2010SE |
| K100617 | Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20DDQA · Special | 05/28/2010SE |
| K094046 | LNCS Oximetry Sensors, Reprocessed LNCS Oximetry SensorsDQA · Special | 05/14/2010SE |
| K091241 | Masimo Rainbow Set Radical 7 Pulse Co-Oximeter; Rad 87 Pulse Co-OximeterDQA · Traditional | 11/06/2009SE |
| K092838 | Masimo Set Rad 8 Pulse Oximeter and Accessories, Model Rad 8DQA · Special | 10/15/2009SE |
| K090662 | Masimo Set Reusable Soft Oximetry Sensors - Adult / Pedicatrics, Model Dbi/ DbipDQA · Traditional | 08/10/2009SE |
| K083719 | LNCS Oximetry SensorsNLF · Traditional | 07/30/2009SE |
| K091057 | Masimo Rainbow Set Pronto Pulse Co-Oximeter and AccessoriesDQA · Special | 07/09/2009SE |
| K090165 | Rainbow Resposable Pulse Co-Oximeter Sensors, Models R2C-25, R2-25, R2C-20 and R2-20DQA · Traditional | 07/09/2009SE |
| K083622 | LNCS Oximetry SensorsDQA · Traditional | 04/02/2009SE |
| K082052 | Masimo Rainbow Set Radcheck Pulse Co-Oximeter, Radcheck, Rad 57 Spot CheckDQA · Traditional | 10/10/2008SE |
| K081659 | Rainbow Adhesive Co-Oximetry Sensor, Models RI-25-L, RI-25, RI-20 and RI-20-LDQA · Traditional | 09/09/2008SE |
| K080238 | Masimo Rainbow Set Radical 7 Pulse Co-Oximeter, Masimo Rainbow Set Rad 87 Pulse…DQA · Traditional | 05/12/2008SE |
| K073024 | Masimo Rainbow Set Rad 87 Pulse Co-Oximeter and AccessoriesDQA · Special | 02/08/2008SE |
| K071024 | Modification to: Rainbow Adhesive Co-Oximetry SensorsDQA · Special | 06/29/2007SE |
| K071047 | Masimo Patient Safety NetMSX · Traditional | 06/08/2007SE |
| K063140 | Rainbow Adhesive Co-Oximetry SensorsDQA · Special | 12/29/2006SE |
| K061204 | Masimo Set Radical 7 Pulse Co-OximeterDQA · Traditional | 07/27/2006SE |
| K060143 | LNCS and SPO2.COM SensorsDQA · Traditional | 06/16/2006SE |
| K053477 | Masimo Set Rad 57 CM and M Pulse Co-OximetersDQA · Traditional | 03/16/2006SE |
| K053269 | Masimo Set RAD-8 Pulse OximeterDQA · Special | 12/21/2005SE |
| K051439 | Lnop Blue Oximetry SensorDQA · Traditional | 07/15/2005SE |
| K051212 | Modification to LNCS Oximetry SensorsDQA · Special | 07/12/2005SE |
| K050252 | AC-1 Adapter Cable, 8 Pin and 12 Pin PhilipsDQA · Special | 05/11/2005SE |
| K050068 | Lnopv Ad-L and Pd-L Oximetry SensorsDQA · Special | 02/09/2005SE |
| K042536 | Masimo Set Rad 57 Pulse Co-OximeterDQA · Traditional | 01/19/2005SE |
| K042346 | LNCS Oximetry SensorsDQA · Special | 09/20/2004SE |
| K041815 | LNCS Oximetry SensorsDQA · Special | 07/29/2004SE |
| K041204 | NC SP02 Adapter CableDQA · Special | 06/29/2004SE |
| K040259 | Masimo Set Intellivue Pulse Oximeter ModuleDQA · Traditional | 04/22/2004SE |
| K033998 | Masimo Set RAD-5V Pulse Oximeter, Model RAD-5VDQA · Traditional | 03/19/2004SE |
| K040214 | Modification to: Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of…DQA · Special | 02/25/2004SE |
| K033296 | Masimo Set RAD-5 Pulse Oximeter, Model RAD-5; Masimo Set RAD-5V Pulse Oximeter, Model…DQA · Traditional | 02/19/2004SE |
| K032551 | Masimo Lnop-Tf-I Resuable Transflectance SensorDQA · Special | 02/19/2004SE |
| K033349 | AC-1 SP02 Adaptor Cable, Model AC-1DQA · Special | 01/28/2004SE |
| K033298 | SPO2.COM Oximetry Sensors, Multiple ModelsDQA · Special | 12/12/2003SE |
| K031330 | Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of…DQA · Special | 05/12/2003SE |
| K013792 | Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of…DQA · Special | 12/11/2001SE |
| K012992 | Masimo Set Radical Pulse Oximeter with Satshare and Masimo Series of Sensors and CablesDQA · Special | 10/03/2001SE |
| K011851 | Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and CablesDQA · Special | 07/11/2001SE |
| K010419 | Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and CablesDQA · Special | 03/06/2001SE |
| K003244 | Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of…DQA · Special | 11/08/2000SE |
| K003167 | Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and CablesDQA · Special | 11/08/2000SE |
| K002939 | Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of…DQA · Special | 10/06/2000SE |
| K002751 | Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and CablesDQA · Special | 10/05/2000SE |
| K002682 | Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of…DQA · Special | 09/13/2000SE |
| K002477 | Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and CablesDQA · Special | 09/08/2000SE |
| K002574 | Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables…DQA · Special | 09/06/2000SE |
| K000126 | Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop-Adt-Adult/Pediatric…DQA · Traditional | 04/14/2000SE |
| K993555 | Masimo Set/Quartz 2500 Pulse Oximeter and AccessoriesDQA · Special | 11/19/1999SE |
| K992340 | Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop -Adt-Adult/Pediatric…DQA · Traditional | 10/08/1999SE |
| K992238 | Masimo Set Radical Pulse Oximeter, Lnop-Adt, Lnop-Pdt, Lnop-Neo, Lnop-Neo PT, Lnop-Dci…DQA · Traditional | 10/08/1999SE |
| K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable Sensor…DQA · Traditional | 06/07/1999SE |
| K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and CablesDQA · Traditional | 01/08/1998SE |
| K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesDQA · Traditional | 02/06/1997SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2671-2026 Class II | Radius VSM Disposable NIBP Cuff, REF: 4825, 4826Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect… | 02/20/2026Open, Classified |
| Z-2670-2026 Class II | Radius VSM ECG pre-connected Set, REF: 4842, 4695Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect… | 02/20/2026Open, Classified |
| Z-1539-2024 Class II | 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. | 02/15/2024Open, Classified |
| Z-1538-2024 Class II | 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. | 02/15/2024Open, Classified |
| Z-1537-2024 Class II | 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. | 02/15/2024Open, Classified |
| Z-1536-2024 Class II | 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. | 02/15/2024Open, Classified |
| Z-1986-2023 Class II | Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503TC-I tip clip sensor may produce readings outside the accuracy specification. | 04/21/2023Open, Classified |
| Z-1985-2023 Class II | Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895TC-I tip clip sensor may produce readings outside the accuracy specification. | 04/21/2023Open, Classified |
| Z-1984-2023 Class II | Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794TC-I tip clip sensor may produce readings outside the accuracy specification. | 04/21/2023Open, Classified |
| Z-1983-2023 Class II | Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053TC-I tip clip sensor may produce readings outside the accuracy specification. | 04/21/2023Open, Classified |
| Z-0338-2016 Class II | rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW…These sensors were manufactured with incompatible configurations. This could result in sensors that will… | 10/28/2015Terminated |
| Z-0213-2015 Class II | Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable…Firm has identified a small number of Oximetry Cables with crossed-internal wires. The effect on performance… | 09/30/2014Terminated |
| Z-1187-2013 Class II | Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated…Masimo has identified a very small number (0.02%) of Rad-8 devices with 20-pin patient cable connector that… | 03/13/2013Terminated |
| Z-1387-2011 | Masimo Hemoglobin Pronto-7 with Rainbow 40 Technology for easy-to-use spot-check testing…Masimo Corporation is initiating a voluntary recall on the Pronto-7 rainbow 4D Resuable Sensor because when… | 12/23/2010Terminated |