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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 12 of 21

Device	Model / Reference	Registries	Class	Status
NomoLine™ LH Adult/Pediatric Airway Adapter Set 4m	4620	FDA UDI	Class I	Active
LNCS® DCI® Reusable Starter Kit	2224	FDA UDI	Class II	Active
MasimoSET Red 25 PC-12 LNOP® Patient Cable	3344	FDA UDI	Class II	Active
Rad-57™ Pulse CO-Oximeter™	3735	FDA UDI	Class II	Active
MasimoSET® M-LNC-14 M-LNCS™ Series Patient Cable	2526	FDA UDI	Class II	Active
Lncs	4715	FDA UDI	Class II	Active
MasimoSET® LNC MP4 LNCS® to IVM/MMS	3755	FDA UDI	Class II	Active
MightySat, Bluetooth, Fingertip Pulse Oximeter	9800	FDA UDI	Class II	Active
Nomoline	9922	FDA UDI	Class II	Active
RD SedlLine	4316	FDA UDI	Class II	Active
MasimoSET® LNOPv™In SpO2 Pulse Oximeter Adhesive Sensor infant	1832	FDA UDI	Class II	Active
Nomoline™ Nomo Extension	Nomo Extension	FDA UDI	Class I	Unknown
Radius-PPG	4587	FDA UDI	Class II	Active
MyView™ Presence Tag	3715	FDA UDI	Class II	Active
MasimoSET ReSposable MAC 395 S-ROS 12U N-395 SpO2 Reusable Optical Sensor (ROS)	2566	FDA UDI	Class II	Active
MasimoSET® Standard Petite Wrap	1598	FDA UDI	Class II	Active
NomoLine™ HH Adult/Pediatric Airway Adapter Set 3m	3828	FDA UDI	Class II	Active
Red LNC MD20-14 LNCS® Patient Cable	4254	FDA UDI	Class II	Active
MightySat	9709	FDA UDI	Class II	Active
SafetyNet	9095	FDA UDI	Class II	Active
MasimoSET	4323	FDA UDI	Class II	Active
MasimoSET® PC-08-DB9 LNOP® to DB9 Connector Patient Cable	2289	FDA UDI	Class II	Active
Masimo W1	95080-103	FDA UDI	Class II	Active
RD rainbow	4036	FDA UDI	Class II	Active
MasimoSET® M-LNC-14-DB9 M-LNCS™ to DB9 Patient Cable	2536	FDA UDI	Class II	Active
NomoLine™ Adult Nasal CO2 Cannula with O2 and Luer	3807	FDA UDI	Class II	Active
Rad-97	9799	EUDAMEDFDA UDI	Class II	Active
Masimo W1	95080-107	FDA UDI	Class II	Active
MasimoSET® IntelliVue Module signal extraction pulse oximeter	1846	FDA UDI	Class II	Active
MasimoSET® rainbow R25 SpCO SpO2 SpMet® Adult Pulse CO-Oximeter® Adhesive Sensor	2221	FDA UDI	Class II	Active
Lncs	2687	FDA UDI	Class II	Active
MasimoSET® Replacement Wraps	2307	FDA UDI	Class II	Active
MasimoSET	4319	FDA UDI	Class II	Active
NomoLine™ Comfort HH Adult Nasal CO2 Cannula	4731	FDA UDI	Class II	Active
MasimoSET® ProCal+™ LNOP SpO2 Extension Cable	2014	FDA UDI	Class II	Active
M-LNC-10-NK M-LNCs™ to NK Patient Cable	3985	FDA UDI	Class II	Active
MasimoSET	3849	FDA UDI	Class II	Active
Rad-87™ Horizontal signal extraction pulse co-oximeter®	9344	FDA UDI	Class II	Active
RD rainbow	4713	FDA UDI	Class II	Active
NomoLine™ LH Pediatric Nasal/Oral CO2 Cannula with O2 4m	4629	FDA UDI	Class I	Active
Isa™ Ax+	AX+ LEMO	FDA UDI	Class II	Active
NomoLine-O™ LH Adult Nasal CO2 Cannula 4m	4632	FDA UDI	Class I	Active
RD rainbow SET-2	4028	FDA UDI	Class II	Active
Rad-57™ Pulse CO-Oximeter™	9472	FDA UDI	Class II	Active
MasimoSET® M-LNCS™ Newborn SpO2 Infant/Pediatric Pulse Oximeter Adhesive Sensor	2520	FDA UDI	Class II	Active
NomoLine-O LH Pediatric Nasal CO2 Cannula with O2	4457	FDA UDI	Class II	Active
RainbowSET RAM Dual Cable, LNC-10	3661	FDA UDI	Class II	Active
MasimoSET® LNCS® Neo-3 SpO2 Neonatal/Adult Pulse Oximeter Adhesive Sensor	2604	EUDAMEDFDA UDI	Class II	Active
Radius VSM	9035	FDA UDI	Class II	Active
uSpO2 Pulse Oximetry Cable for GE ApexPro® CH, CARESCAPE™ Telemetry T4 & T14	3577	FDA UDI	Class II	Active

Related Companies

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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.