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 4 of 21

Device	Model / Reference	Registries	Class	Status
MasimoSET® LNCS® Adtx SpO2 Adult Pulse Oximeter Adhesive Sensor	1859	FDA UDI	Class II	Active
Sedline™ Monitor	9185	FDA UDI	Class II	Active
Radius T	4776	FDA UDI	Class II	Active
RD rainbow SET™ R25-08 RD rainbow SET Series Patient Cable	4106	FDA UDI	Class II	Active
Rd Set	4476	FDA UDI	Class II	Active
MasimoSET® LNOP® Neo-L neonatal/adult SpO2 adhesive sensor	1966	FDA UDI	Class II	Active
MasimoSET® LNC-4-GE LNCS® to GE Patient Cable	2430	FDA UDI	Class II	Active
MasimoSET® LNCS® NeoPt-L SpO2 Neonatal Pulse Oximeter Adhesive Sensor	1901	EUDAMEDFDA UDI	Class II	Active
Lncs	4714	FDA UDI	Class II	Active
EMMA™ Capnometer	kPa	FDA UDI	Class II	Unknown
MasimoSET® LNOP® Pdtx SpO2 Pediatric Pulse Oximeter Adhesive Sensor	1830	FDA UDI	Class II	Active
rainbow SET	4100	FDA UDI	Class II	Active
RD SpO2	4871	FDA UDI	Class II	Active
Rad-87™ Horizontal signal extraction pulse co-oximeter®	9227	FDA UDI	Class II	Active
Data Transfer™ Download Cable, 14 pin	1909	FDA UDI	Class II	Active
Lncs-Ii	4070	FDA UDI	Class II	Active
Nomoline ISA CO2	4199	FDA UDI	Class II	Active
4D DC Sensor, Large	9402	FDA UDI	Class II	Active
MasimoSET® LNCS® Patient Cable LNCv-10	3508	FDA UDI	Class II	Active
MasimoSET® Transflectance Sensor Adhesive Pads	1903	FDA UDI	Class II	Active
NomoLine-O LH Adult Nasal CO2 Cannula	4455	FDA UDI	Class II	Active
MasimoSET® PC12 LNOP® Series Patient Cable	1006	FDA UDI	Class II	Active
Radius-7	4196	FDA UDI	Class II	Active
MasimoSET® M-LNCS™ Pdtx-3 SpO2 Pediatric Pulse Oximeter Adhesive Sensor	2511	FDA UDI	Class II	Active
SatShare™ Interface MQ01 Cable	1321	FDA UDI	Class II	Active
NomoLine™ Adult Nasal CO2 Cannula with Luer	3804	FDA UDI	Class II	Active
Rad-97	9798	FDA UDI	Class II	Active
SatShare™ Interface DS01 Cable	1325	FDA UDI	Class II	Active
SpO2.COM® pediatric SpO2 disposable sensor	1775	FDA UDI	Class II	Active
NomoLine	4992	FDA UDI	Class I	Active
MasimoSET® LNCS® DCI-Pv pediatric/slender digit SpO2 reusable sensor	3504	FDA UDI	Class II	Active
Sedline	9829	FDA UDI	Class II	Active
RD to LNC Adapter Cable RD SET™ to LNC Adapter Cable 1.5 ft.	4105	FDA UDI	Class II	Active
Rad-G	9210	FDA UDI	Class II	Active
NomoLine-O	4934	FDA UDI	Class II	Active
Masimo	9783	EUDAMEDFDA UDI	Class II	Active
DCIP SC 400 400 spot checks Pediatric/Slender digit Reusable Sensor	3421	FDA UDI	Class II	Active
Rad-G	4653	FDA UDI	Class II	Active
RD to PC Adapter Cable RD SET™ to PC Adapter Cable	4088	FDA UDI	Class II	Active
LNCS SpO2	4874	FDA UDI	Class II	Active
LNOP® NeoPt-L neonatal SpO2 adhesive sensor	1967	FDA UDI	Class II	Active
MasimoSET® rainbow Replacement Tapes for R25-L Sensors	2324	FDA UDI	Class II	Active
NomoLine	4989	FDA UDI	Class I	Active
MasimoSET® Red DCI-dc12 SpO2 Adult Reusable Sensor	2054	FDA UDI	Class II	Active
Isa™ Co2	CO2 ROOT	FDA UDI	Class II	Active
Resposable S-DOS 25Pt-L SpO2 Neonatal Pulse Oximeter Disposable Optical Sensor	2476	FDA UDI	Class II	Active
Radius-PPG	4585	FDA UDI	Class II	Active
Isa™ Or+	OR+	FDA UDI	Class II	Active
RD SpO2	4875	FDA UDI	Class II	Active
Isa™ Ax+	AX+	FDA UDI	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.