Is this your brand? Sign in to claim ownership.

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 19 of 21

Device	Model / Reference	Registries	Class	Status
Masimo Root Monitoring System and Accesories	K142394	FDA 510(k)	Class II	Active
Masimo Rainbow Set Radical 7 Pulse Co-Oximeter; Rad 87 Pulse Co-Oximeter	K091241	FDA 510(k)	Class II	Active
Carescape SpO2 - Masimo	K212876	FDA 510(k)	Class II	Active
Masimo Set And Masimo Rainbow Set Pulse Oximeters And Sensors	K120657	FDA 510(k)	Class II	Active
Masimo Root Monitoring System and Accessories	K171121	FDA 510(k)	Class II	Active
LiDCO to B. Braun, BP Module Cable	5125	EUDAMED	Class I	Active
LiDCO to Drager, Analog Cable	5131	EUDAMED	Class I	Active
Radius PPG Wireless Receiver	4589	EUDAMEDFDA UDI	Class IIb	Active
LiDCO Module	95060	EUDAMEDFDA UDI	Class IIb	Active
LiDCO to GE 6/7000, Analog Cable	5140	EUDAMED	Class I	Active
Masimo Rainbow Set Radical 7 Pulse Co-Oximeter, Masimo Rainbow Set Rad 87 Pulse Co-Oximeter	K080238	FDA 510(k)	Class II	Active
Masimo Rad-97 and Accessories	K183697	FDA 510(k)	Class II	Active
Masimo Lnop-Tf-I Resuable Transflectance Sensor	K032551	FDA 510(k)	Class II	Active
Rainbow Adhesive Co-Oximetry Sensor, Models Ri-25-L, Ri-25, Ri-20 And Ri-20-L	K081659	FDA 510(k)	Class II	Active
Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter	K162675	FDA 510(k)	Class II	Active
Masimo CARESCAPE SpO2 – Masimo with SpHb	K221953	FDA 510(k)	Class II	Active
Modification To: Masimo Set Radical Pulse Oximeter With Satshare And Lnop Series Of Sensors And Cables	K040214	FDA 510(k)	Class II	Active
Masimo Set Rad-8 Pulse Oximeter	K053269	FDA 510(k)	Class II	Active
Masimo Rad-97 and Accessories	K191059	FDA 510(k)	Class II	Active
Masimo O3 Regional Oximeter System	K214072	FDA 510(k)	Class II	Active
Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories	K212161	FDA 510(k)	Class II	Active
Masimo Rainbow Set Pronto-7 Pulse Co-Oximeter And Accessories	K111403	FDA 510(k)	Class II	Active
ORi	DEN200076	FDA 510(k)	Class II	Active
Nc Sp02 Adapter Cable	K041204	FDA 510(k)	Class II	Active
Masimo Set Radical Pulse Oximeter With Satshare And Masimo Series Of Sensors And Cables	K012992	FDA 510(k)	Class II	Active
Lnop Blue Oximetry Sensor	K051439	FDA 510(k)	Class II	Active
Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5v Pulse Oximeter, Model Rad-5v	K033296	FDA 510(k)	Class II	Active
SedLine Sedation Monitor	K172890	FDA 510(k)	Class II	Active
Modification To Masimo Set Radical Pulse Oximeter With Satshare And Lnop Series Of Sensors And Cables	K031330	FDA 510(k)	Class II	Active
E1 Ear Sensors	K121912	FDA 510(k)	Class II	Active
Masimo Set/Quartz 2500 Pulse Oximeter And Accessories	K993555	FDA 510(k)	Class II	Active
Masimo Rad-97 and Accessories	K180046	FDA 510(k)	Class II	Active
Masimo Rainbow Set Radcheck Pulse Co-Oximeter, Radcheck, Rad 57 Spot Check	K082052	FDA 510(k)	Class II	Active
Masimo Lncs/M-Lncs Oximetry Sensors	K101896	FDA 510(k)	Class II	Active
Masimo O3 Regional Oximeter	K243324	FDA 510(k)	Class II	Active
Masimo SafetyNet	DEN200011	FDA 510(k)	Class II	Active
Modification To Masimo Set Radical Pulse Oximeter With Satshare And Lnop Series Of Sensors And Cables	K013792	FDA 510(k)	Class II	Active
Masimo Set Radical Pulse Oximeter With Satshare And Lnop Series Of Sensors And Cables	K003167	FDA 510(k)	Class II	Active
Masimo Set Reusable Soft Oximetry Sensors - Adult / Pedicatrics, Model Dbi/ Dbip	K090662	FDA 510(k)	Class II	Active
Lncs Oximetry Sensors, Reprocessed Lncs Oximetry Sensors	K094046	FDA 510(k)	Class II	Active
Masimo Set Rad 57 Pulse Co-Oximeter	K042536	FDA 510(k)	Class II	Active
Masimo Radical Y Pulse Co-Oximeter	K110028	FDA 510(k)	Class II	Active
Masimo Set Radical Pulse Oximeter With Satshare And Lnop Series Of Sensors And Cables, Model Radical, Lnop-Adt, Lnop-Pdt	K002574	FDA 510(k)	Class II	Active
Masimo Rad-G with Temperature	K213676	FDA 510(k)	Class II	Active
Rainbow Resposable Pulse Co-Oximeter Sensors, Models R2c-25, R2-25, R2c-20 And R2-20	K090165	FDA 510(k)	Class II	Active
Masimo Set Radical Pulse Oximeter With Satshare And Lnop Series Of Sensors And Cables	K002477	FDA 510(k)	Class II	Active
Masimo SedLine Sedation Monitor and Accessories	K203113	FDA 510(k)	Class II	Active
Spo2.com Oximetry Sensors, Multiple Models	K033298	FDA 510(k)	Class II	Active
Modification To Lncs Oximetry Sensors	K051212	FDA 510(k)	Class II	Active
Masimo Rainbow Set Pronto -7 Pulse Co- Oximeter And Accessories, Model Pronto-7	K100403	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

MDSS GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.