Company · US
Masimo Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2026. Name variants (Inc, Corp, punctuation) are merged.
116510(k) clearances (4 in 12 months)
16recalls (2 in 12 months)
15recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DQA | Oximeter | 91 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 13 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 6 |
| MUD | Oximeter, Tissue Saturation | 6 |
| DPS | Electrocardiograph | 3 |
| OLW | Index-Generating Electroencephalograph Software | 3 |
| NLF | Oximeter, Reprocessed | 2 |
| BZQ | Monitor, Breathing Frequency | 1 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 |
| FLL | Continuous Measurement Thermometer | 1 |
| MSX | System, Network And Communication, Physiological Monitors | 1 |
| OLK | Pulse Oximeter For Over-The-Counter Use | 1 |
| QVT | Monitor For Opioid Induced Impairment Of Oxygenation | 1 |
| QWE | Hyperoxia Monitoring Device Adjunct To Pulse Oximetry | 1 |
| QYU | Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 14, 2026 | K260676 | Radius VSM and Accessories Masimo Corporation | MHX |
| Aug 12, 2026 | K253417 | Masimo Root Monitoring System Masimo Corporation | MWI |
| Jul 10, 2026 | K260880 | SedLine Sedation Monitor Masimo Corporation | OLW |
| Jun 4, 2026 | K254209 | Radius VSM and Accessories Masimo Corporation | MHX |
| Jul 17, 2025 | K243324 | Masimo O3 Regional Oximeter Masimo Corporation | MUD |
| May 29, 2025 | K250757 | Radius VSM and Accessories Masimo Corporation | MHX |
| Apr 3, 2025 | K243305 | Masimo W1 Masimo Corporation | DPS |
| Aug 8, 2024 | K240229 | Masimo W1 Masimo Corporation | DPS |
| May 3, 2024 | K234021 | Masimo Stork Masimo Corporation | QYU |
| Jan 31, 2024 | K214115 | MightySat -OTC Masimo Corporation | OLK |
| Dec 15, 2023 | K223721 | Masimo Stork Masimo Corporation | DQA |
| Nov 17, 2023 | K232512 | Masimo W1 Masimo Corporation | DPS |
| Oct 12, 2023 | DEN200076 | ORi Masimo Corporation | QWE |
| Sep 7, 2023 | K232389 | Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue Masimo Corporation | DQA |
| Jun 1, 2023 | K223498 | Radius VSM and Accessories Masimo Corporation | MHX |
| Apr 16, 2023 | K213676 | Masimo Rad-G with Temperature Masimo Corporation | DQA |
| Mar 31, 2023 | DEN200011 | Masimo SafetyNet Masimo Corporation | QVT |
| Mar 6, 2023 | K212161 | Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories Masimo Corporation | MWI |
| Aug 4, 2022 | K221953 | Masimo CARESCAPE SpO2 Masimo with SpHb Masimo Corporation | DQA |
| May 6, 2022 | K214072 | Masimo O3 Regional Oximeter System Masimo Corporation | MUD |
| Feb 25, 2022 | K203113 | Masimo SedLine Sedation Monitor and Accessories Masimo Corporation | OLW |
| Oct 8, 2021 | K212876 | Carescape SpO2 - Masimo Masimo Corporation | DQA |
| Jun 11, 2021 | K203215 | Radius T wearable thermometer Masimo Corporation | FLL |
| Mar 29, 2021 | K201590 | EMMA Capnograph Masimo Corporation | CCK |
| Sep 24, 2020 | K201770 | Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor Masimo Corporation | DQA |
| Aug 29, 2020 | K201432 | Masimo O3 Regional Oximeter System Masimo Corporation | MUD |
| Aug 10, 2020 | K193626 | Masimo Rad-97 Pulse CO-Oximeter and Accessories Masimo Corporation | MWI |
| Apr 22, 2020 | K191882 | Masimo Centroid System Masimo Corporation | MWI |
| Feb 27, 2020 | K193242 | Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pul Masimo Corporation | MWI |
| Dec 27, 2019 | K191059 | Masimo Rad-97 and Accessories Masimo Corporation | MWI |
| Jun 7, 2019 | K182429 | Masimo O3 Regional Oximeter System Masimo Corporation | MUD |
| May 15, 2019 | K183697 | Masimo Rad-97 and Accessories Masimo Corporation | MWI |
| Mar 22, 2019 | K182887 | Masimo Rad-67 Pulse CO-Oximeter and Accessories Masimo Corporation | DQA |
| Jan 23, 2019 | K181956 | Masimo MightySat Rx Fingertip Pulse Oximeter Masimo Corporation | DQA |
| Oct 23, 2018 | K180046 | Masimo Rad-97 and Accessories Masimo Corporation | DQA |
| Sep 5, 2018 | K173976 | Masimo Acoustic Respiration Sensors, infant and neonate Masimo Corporation | BZQ |
| Jan 26, 2018 | K172890 | SedLine Sedation Monitor Masimo Corporation | OLW |
| Nov 17, 2017 | K171121 | Masimo Root Monitoring System and Accessories Masimo Corporation | MWI |
| Sep 14, 2017 | K170168 | Masimo Rad-97 and Accessories Masimo Corporation | MWI |
| May 26, 2017 | K162603 | Masimo O3 Regional Oximeter System Masimo Corporation | MUD |
| Dec 28, 2016 | K162675 | Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter Masimo Corporation | DQA |
| Nov 23, 2016 | K160940 | Masimo Disposable Transflectance Forehead Sensor Masimo Corporation | DQA |
| Jun 21, 2016 | K153225 | Masimo Root Monitoring System and Accessories Masimo Corporation | MWI |
| Jun 9, 2016 | K160526 | Masimo O3 Regional Oximeter System Masimo Corporation | MUD |
| Feb 12, 2016 | K151644 | Masimo Root Vital Signs Monitoring System and Accessories Masimo Corporation | MWI |
| Oct 22, 2015 | K150314 | Masimo MightySat Rx Fingertip Pulse Oximeter Masimo Corporation | DQA |
| Nov 25, 2014 | K142394 | Masimo Root Monitoring System and Accesories Masimo Corporation | MWI |
| Jun 25, 2014 | K140188 | MASIMO ROOT MONITORING SYSTEM Masimo Corporation | MWI |
| Apr 26, 2013 | K120984 | MASIMO RAS-125C ACOUSTIC RESPIRATION SENSOR Masimo Corporation | DQA |
| Sep 19, 2012 | K120657 | MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS Masimo Corporation | DQA |
Newest 50 of 116.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2026 | Masimo Corporation Radius VSM Disposable NIBP Cuff, REF: 4825, 4826 Open, Classified |
MHX | K223498 |
| Jul 2, 2026 | Masimo Corporation Radius VSM ECG pre-connected Set, REF: 4842, 4695 Open, Classified |
MHX | K223498 |
| Apr 12, 2024 | Masimo Corporation Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only, Open, Classified |
DQA | K213676 |
| Apr 12, 2024 | Masimo Corporation Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only, Open, Classified |
DQA | K201770 |
| Apr 12, 2024 | Masimo Corporation Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only, Open, Classified |
DQA | K201770 |
| Apr 12, 2024 | Masimo Corporation Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only, Open, Classified |
DQA | K213676 |
| Jun 21, 2023 | Masimo Corporation Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503 Open, Classified |
DQA | K051212 |
| Jun 21, 2023 | Masimo Corporation Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895 Open, Classified |
DQA | K051212 |
| Jun 21, 2023 | Masimo Corporation Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794 Open, Classified |
DQA | K033296 |
| Jun 21, 2023 | Masimo Corporation Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053 Open, Classified |
DQA | K180046 |
| Nov 25, 2015 | Masimo Corporation 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/SpC Terminated |
DQA | K080238 |
| Nov 13, 2014 | Masimo Corporation 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 p Terminated |
DQA | K121914 |
| Apr 29, 2013 | Masimo Corporation 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 p Terminated |
DQA | None listed |
| Feb 22, 2011 | Masimo Corporation 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 accesso Terminated |
DQA | K100403 |
| Mar 18, 2006 | Masimo Corporation Rainbow DC-I-DC Pulse CO-Oximeter Sensor used with the Masimo SET Rad 57 Pulse CoOximeter Terminated |
DQA | K042536 |
| Jun 25, 2005 | Masimo Corporation Radical Handheld Pulse Oximeter Terminated |
DQA | K992340 |