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 21 of 21

Device	Model / Reference	Registries	Class	Status
Masimo O3 Regional Oximeter System	K160526	FDA 510(k)	Class II	Active
Radius VSM and Accessories	K223498	FDA 510(k)	Class II	Active
Masimo O3 Regional Oximeter System	K182429	FDA 510(k)	Class II	Active
Lncs And Spo2.com Sensors	K060143	FDA 510(k)	Class II	Active
Masimo W1	K243305	FDA 510(k)	Class II	Active
Masimo Patient Safety Net	K071047	FDA 510(k)	Class II	Active
Modification To Masimo Set Radical Pulse Oximeter With Satshare And Lnop Series Of Sensors And Cables	K002682	FDA 510(k)	Class II	Active
Radius T wearable thermometer	K203215	FDA 510(k)	Class II	Active
M-Lncs Oximetry Sensors, Reprocessed M-Lncs Oximetry Sensors	K110723	FDA 510(k)	Class II	Active
Modification To Masimo Set Radical Pulse Oximeter With Satshare And Lnop Series Of Senors Oximeter	K002939	FDA 510(k)	Class II	Active
Radius VSM and Accessories	K250757	FDA 510(k)	Class II	Active
Lncs Oximetry Sensors	K083622	FDA 510(k)	Class II	Active
Masimo Set Rad-5v Pulse Oximeter, Model Rad-5v	K033998	FDA 510(k)	Class II	Active
Masimo Set Radical Pulse Oximeter With Satshare, Masimo Lnop-Adt-Adult/Pediatric Disposable Sensor, Masimo Lno-Pdt-Pedia	K000126	FDA 510(k)	Class II	Active
LiDCO to MR MPM, Analog Cable	5134	EUDAMED	Class I	Active
LiDCO to ICU Medical, BP Module Cable	5122	EUDAMED	Class I	Active
rainbow SET Pulse CO-Oximetry Cable, GE Carescape Sp02, Masimo	4234	EUDAMEDFDA UDI	Class IIb	Active
LiDCO to Smiths Medical, BP Module Cable	5124	EUDAMED	Class I	Active
LiDCO to NK, Analog Cable	5132	EUDAMED	Class I	Active
LiDCO Module	95059	EUDAMEDFDA UDI	Class IIb	Active
LiDCO to MR iPM, Analog Cable	5139	EUDAMED	Class I	Active
LiDCO to Datex, Analog Cable	5133	EUDAMED	Class I	Active
LiDCO to Utah, BP Module Cable	5126	EUDAMED	Class I	Active
LiDCO to Codan, BP Module Cable	5123	EUDAMED	Class I	Active
rainbow SET Pulse CO-Oximetry Cable, Carescape Sp02, Masimo, 0.9m Cable	4182	EUDAMEDFDA UDI	Class IIb	Active
LiDCO to MR T5 to T9, Analog Cable	5137	EUDAMED	Class I	Active
LiDCO to Merit Medical, BP Module Cable	5120	EUDAMED	Class I	Active
LiDCO to GE Marquette, Analog Cable	5129	EUDAMED	Class I	Active
LiDCO to Edwards, BP Module Cable	5121	EUDAMED	Class I	Active
LiDCO to MR Benevision, Analog Cable	5130	EUDAMED	Class I	Active
LiDCO to Fukuda Denshi, Analog Cable	5136	EUDAMED	Class I	Active
LiDCO to GE PDM, Analog Cable	5128	EUDAMED	Class I	Active
LiDCO to BNC, Analog Cable	5138	EUDAMED	Class I	Active
LiDCO to Philips, Analog Cable	5127	EUDAMED	Class I	Active
LiDCO to SL, Analog Cable	5135	EUDAMED	Class I	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.