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MASIMO CORPORATION

Verified

United States·US-MF-000010641

Last updated September 17, 2026

About

Masimo is a global medical technology company that develops and manufactures innovative noninvasive patient monitoring technologies, medical devices, and a wide array of sensors. The company's mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. Best known for its Signal Extraction Technology (SET) pulse oximetry, Masimo also produces devices for measuring blood oxygen saturation, pulse rate, perfusion index, pleth variability index, and total haemoglobin. Headquartered in Irvine, California, with 9,000+ employees worldwide.

Information

Country: United States
Address: 52, Discovery, Irvine, United States
Website: www.masimo.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 (949) 297-7000
PRRC Contact: Mathew Jimenez
EUDAMED SRN: US-MF-000010641
FDA FEI Number: 3011353843
DUNS Number: 780421038

Catalogue (1035)

Page 20 of 21

Device	Model / Reference	Registries	Class	Status
Masimo Rainbow Set Radical 7r Pulse Co-Oximeter	K100428	FDA 510(k)	Class II	Active
Masimo O3 Regional Oximeter System	K201432	FDA 510(k)	Class II	Active
Masimo Set Ms-1 Pulse Oximeter & The Lnop Series Of Sensors & Cables	K962603	FDA 510(k)	Class II	Active
Masimo Set Reusable Oximetry Sensors	K113596	FDA 510(k)	Class II	Active
Masimo Set Radical Pulse Oximeter With Satshare And Lnop Series Of Sensors And Cables	K002751	FDA 510(k)	Class II	Active
Masimo Acoustic Respiration Sensors, infant and neonate	K173976	FDA 510(k)	Class II	Active
Masimo Set Radical Pulse Oximeter, Lnop-Adt, Lnop-Pdt, Lnop-Neo, Lnop-Neo Pt, Lnop-Dci, Patient Cable (pc04, Pc08, Pc12)	K992238	FDA 510(k)	Class II	Active
Masimo Lnop/Lncs/M-Lncs Multisite-L Oximetry Sensors	K111888	FDA 510(k)	Class II	Active
Lnopv Ad-L And Pd-L Oximetry Sensors	K050068	FDA 510(k)	Class II	Active
Masimo Stork	K234021	FDA 510(k)	Class II	Active
Masimo Centroid System	K191882	FDA 510(k)	Class II	Active
Masimo W1	K232512	FDA 510(k)	Class II	Active
Lncs Oximetry Sensors	K083719	FDA 510(k)	Class II	Active
Lncs Oximetry Sensors	K042346	FDA 510(k)	Class II	Active
Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue	K232389	FDA 510(k)	Class II	Active
Masimo Set Ms-1p Pulse Oximeter And The Lnop Series Of Sensors And Cables	K973887	FDA 510(k)	Class II	Active
Masimo Rad-97 Pulse CO-Oximeter and Accessories	K193626	FDA 510(k)	Class II	Active
Masimo Set Rad 8 Pulse Oximeter And Accessories, Model Rad 8	K092838	FDA 510(k)	Class II	Active
Masimo Set Radical Pulse Oximeter With Satshare And Lnop Series Of Sensors And Cables	K011851	FDA 510(k)	Class II	Active
Masimo MightySat Rx Fingertip Pulse Oximeter	K181956	FDA 510(k)	Class II	Active
Masimo Stork	K223721	FDA 510(k)	Class II	Active
Masimo Disposable Transflectance Forehead Sensor	K160940	FDA 510(k)	Class II	Active
Masimo Ras-125c Acoustic Respiration Sensor	K120984	FDA 510(k)	Class II	Active
Masimo O3 Regional Oximeter System	K162603	FDA 510(k)	Class II	Active
EMMA Capnograph	K201590	FDA 510(k)	Class II	Active
Masimo Set 2000 Pulse Oximeter, Masimo Lnop -adt-Adult/Pediatric Disposable Sensor, Masimo Lnop -pdt-Pediatric/Small Dis	K990966	FDA 510(k)	Class II	Active
Masimo Root Vital Signs Monitoring System and Accessories	K151644	FDA 510(k)	Class II	Active
Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories	K193242	FDA 510(k)	Class II	Active
Masimo Rainbow Set Rad 87 Pulse Co-Oximeter And Accessories	K073024	FDA 510(k)	Class II	Active
Masimo Set Radical Pulse Oximeter With Satshare And Lnop Series Of Sensors And Cables	K010419	FDA 510(k)	Class II	Active
Ac-1 Adapter Cable, 8 Pin And 12 Pin Philips	K050252	FDA 510(k)	Class II	Active
Masimo Rad-97 and Accessories	K170168	FDA 510(k)	Class II	Active
Rainbow Adhesive Co-Oximetry Sensors	K063140	FDA 510(k)	Class II	Active
Ac-1 Sp02 Adaptor Cable, Model Ac-1	K033349	FDA 510(k)	Class II	Active
Masimo W1	K240229	FDA 510(k)	Class II	Active
Masimo Rad-67 Pulse CO-Oximeter and Accessories	K182887	FDA 510(k)	Class II	Active
Masimo Disposable Oximetry Ear Sensor, Model E1	K101031	FDA 510(k)	Class II	Active
Modification To Masimo Set Radical Pulse Oximeter With Satshare And Lnop Series Of Sensors And Cables	K003244	FDA 510(k)	Class II	Active
Masimo Set Uspo2 Pulse Oximetry Cable	K121914	FDA 510(k)	Class II	Active
Masimo Responsable Oximetry Sensors Model S2-25/25d; S2-20/20d	K100617	FDA 510(k)	Class II	Active
MightySat -OTC	K214115	FDA 510(k)	Class II	Active
Masimo Set Rad 57 Cm And M Pulse Co-Oximeters	K053477	FDA 510(k)	Class II	Active
Masimo Rainbow Set Pronto Pulse Co-Oximeter And Accessories	K091057	FDA 510(k)	Class II	Active
Masimo Set Intellivue Pulse Oximeter Module	K040259	FDA 510(k)	Class II	Active
Masimo Resposable Spo2 Series Oximetry Sensors, Masimo Lncs / M-Lncs Oximetry Sensors	K111621	FDA 510(k)	Class II	Active
Masimo MightySat Rx Fingertip Pulse Oximeter	K150314	FDA 510(k)	Class II	Active
Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor	K201770	FDA 510(k)	Class II	Active
Modification To: Rainbow Adhesive Co-Oximetry Sensors	K071024	FDA 510(k)	Class II	Active
Lncs Oximetry Sensors	K041815	FDA 510(k)	Class II	Active
Masimo Set Radical Pulse Oximeter With Satshare, Masimo Lnop -adt-Adult/Pediatric Disposable Sensor, Masimo Lnop -pdt-Pe	K992340	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

MDSS GmbH DE

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Authorities

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FDA Recalls (11)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Feb 15, 2024	Z-1538-2024	—	open, classified	Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
Feb 15, 2024	Z-1537-2024	—	open, classified	Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
Feb 15, 2024	Z-1536-2024	—	open, classified	Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
Feb 15, 2024	Z-1539-2024	—	open, classified	Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
Apr 21, 2023	Z-1986-2023	—	open, classified	TC-I tip clip sensor may produce readings outside the accuracy specification.
Apr 21, 2023	Z-1984-2023	—	open, classified	TC-I tip clip sensor may produce readings outside the accuracy specification.
Apr 21, 2023	Z-1985-2023	—	open, classified	TC-I tip clip sensor may produce readings outside the accuracy specification.
Apr 21, 2023	Z-1983-2023	—	open, classified	TC-I tip clip sensor may produce readings outside the accuracy specification.
Dec 23, 2010	Z-1387-2011	—	terminated	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.
Feb 2, 2006	Z-0661-06	—	terminated	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%.
Jun 10, 2005	Z-0933-05	—	terminated	Speaker component failure resulting in ceasation of an audible alarm even though the condition continues that caused the alarm.