Masimo Corporation
Masimo Corporation holds FDA 510(k) medical device clearances, first cleared 2004, most recent 2026, with 11 FDA device recalls on record.
Top product codes for Masimo Corporation
FDA recalls by Masimo Corporation
10 most recent of 11- Z-1537-2024 — Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,
- Z-1538-2024 — Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only,
- Z-1539-2024 — Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only,
- Z-1536-2024 — Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,
- Z-1986-2023 — Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503
- Z-1984-2023 — Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794
- Z-1985-2023 — Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895
- Z-1983-2023 — Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053
- 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.
- 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Masimo Corporation
- K253417 — Masimo Root Monitoring System
- K260880 — SedLine Sedation Monitor
- K254209 — Radius VSM and Accessories
- K243324 — Masimo O3 Regional Oximeter
- K250757 — Radius VSM and Accessories
- K243305 — Masimo W1
- K240229 — Masimo W1
- K234021 — Masimo Stork
- K214115 — MightySat -OTC
- K223721 — Masimo Stork
- K232512 — Masimo W1
- DEN200076 — ORi
- K232389 — Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue
- K223498 — Radius VSM and Accessories
- K213676 — Masimo Rad-G with Temperature
- DEN200011 — Masimo SafetyNet
- K212161 — Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories
- K221953 — Masimo CARESCAPE SpO2 Masimo with SpHb
- K214072 — Masimo O3 Regional Oximeter System
- K203113 — Masimo SedLine Sedation Monitor and Accessories
- K212876 — Carescape SpO2 - Masimo
- K203215 — Radius T wearable thermometer
- K201590 — EMMA Capnograph
- K201770 — Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor
- K201432 — Masimo O3 Regional Oximeter System
- K193626 — Masimo Rad-97 Pulse CO-Oximeter and Accessories
- K191882 — Masimo Centroid System
- 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
- K191059 — Masimo Rad-97 and Accessories
- K182429 — Masimo O3 Regional Oximeter System
- K183697 — Masimo Rad-97 and Accessories
- K182887 — Masimo Rad-67 Pulse CO-Oximeter and Accessories
- K181956 — Masimo MightySat Rx Fingertip Pulse Oximeter
- K180046 — Masimo Rad-97 and Accessories
- K173976 — Masimo Acoustic Respiration Sensors, infant and neonate
- K172890 — SedLine Sedation Monitor
- K171121 — Masimo Root Monitoring System and Accessories
- K170168 — Masimo Rad-97 and Accessories
- K162603 — Masimo O3 Regional Oximeter System
- K162675 — Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter
- K160940 — Masimo Disposable Transflectance Forehead Sensor
- K153225 — Masimo Root Monitoring System and Accessories
- K160526 — Masimo O3 Regional Oximeter System
- K151644 — Masimo Root Vital Signs Monitoring System and Accessories
- K150314 — Masimo MightySat Rx Fingertip Pulse Oximeter
- K142394 — Masimo Root Monitoring System and Accesories
- K140188 — MASIMO ROOT MONITORING SYSTEM
- K120984 — MASIMO RAS-125C ACOUSTIC RESPIRATION SENSOR
- K120657 — MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS
- K121914 — MASIMO SET USPO2 PULSE OXIMETRY CABLE
- K121912 — E1 EAR SENSORS
- K113596 — MASIMO SET REUSABLE OXIMETRY SENSORS
- K111403 — MASIMO RAINBOW SET PRONTO-7 PULSE CO-OXIMETER AND ACCESSORIES
- K111621 — MASIMO RESPOSABLE SPO2 SERIES OXIMETRY SENSORS, MASIMO LNCS / M-LNCS OXIMETRY SENSORS
- K111888 — MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORS
- K110723 — M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS
- K110028 — MASIMO RADICAL Y PULSE CO-OXIMETER
- K101031 — MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1
- K101896 — MASIMO LNCS/M-LNCS OXIMETRY SENSORS
- K100428 — MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETER
- K100403 — MASIMO RAINBOW SET PRONTO -7 PULSE CO- OXIMETER AND ACCESSORIES, MODEL PRONTO-7
- K100617 — MASIMO RESPONSABLE OXIMETRY SENSORS MODEL S2-25/25D; S2-20/20D
- K094046 — LNCS OXIMETRY SENSORS, REPROCESSED LNCS OXIMETRY SENSORS
- K091241 — MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER; RAD 87 PULSE CO-OXIMETER
- K092838 — MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8
- K090662 — MASIMO SET REUSABLE SOFT OXIMETRY SENSORS - ADULT / PEDICATRICS, MODEL DBI/ DBIP
- K083719 — LNCS OXIMETRY SENSORS
- K090165 — RAINBOW RESPOSABLE PULSE CO-OXIMETER SENSORS, MODELS R2C-25, R2-25, R2C-20 AND R2-20
- K091057 — MASIMO RAINBOW SET PRONTO PULSE CO-OXIMETER AND ACCESSORIES
- K083622 — LNCS OXIMETRY SENSORS
- K082052 — MASIMO RAINBOW SET RADCHECK PULSE CO-OXIMETER, RADCHECK, RAD 57 SPOT CHECK
- K081659 — RAINBOW ADHESIVE CO-OXIMETRY SENSOR, MODELS RI-25-L, RI-25, RI-20 AND RI-20-L
- K080238 — MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER
- K073024 — MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER AND ACCESSORIES
- K071024 — MODIFICATION TO: RAINBOW ADHESIVE CO-OXIMETRY SENSORS
- K071047 — MASIMO PATIENT SAFETY NET
- K063140 — RAINBOW ADHESIVE CO-OXIMETRY SENSORS
- K061204 — MASIMO SET RADICAL 7 PULSE CO-OXIMETER
- K060143 — LNCS AND SPO2.COM SENSORS
- K053477 — MASIMO SET RAD 57 CM AND M PULSE CO-OXIMETERS
- K053269 — MASIMO SET RAD-8 PULSE OXIMETER
- K051439 — LNOP BLUE OXIMETRY SENSOR
- K051212 — MODIFICATION TO LNCS OXIMETRY SENSORS
- K050252 — AC-1 ADAPTER CABLE, 8 PIN AND 12 PIN PHILIPS
- K050068 — LNOPV AD-L AND PD-L OXIMETRY SENSORS
- K042536 — MASIMO SET RAD 57 PULSE CO-OXIMETER
- K042346 — LNCS OXIMETRY SENSORS
Data sourced from openFDA. This site is unofficial and independent of the FDA.