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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 13 of 21

Device	Model / Reference	Registries	Class	Status
MasimoSET® SofTouch™ Replacement Wrap	2259	FDA UDI	Class II	Active
iSpO2 Pulse Oximeter Consumer (Small)	3589	FDA UDI	Class II	Active
rainbow® DCI® SC 200 SpHb® SpO2 SpMet® 200 spot checks Adult Reusable Sensor	3418	FDA UDI	Class II	Active
M-Lncs	3856	FDA UDI	Class II	Active
PC-12 NK LNOP® to NK Patient Cable	3983	FDA UDI	Class II	Active
NomoLine™ LH Pediatric Nasal CO2 Cannula with O2	3821	FDA UDI	Class II	Active
Irma™ Co2	CO2 Bluepoint	FDA UDI	Class II	Active
Rad-97	9738	FDA UDI	Class II	Active
MasimoSET® Replacement Tapes	2822	FDA UDI	Class II	Active
MasimoSET® LNCS® Adtx-3 SpO2 Adult Pulse Oximeter Adhesive Sensor	2601	EUDAMEDFDA UDI	Class II	Active
LNCS® Sensor Sample Pack	1899	FDA UDI	Class II	Active
rainbow® DCI® SpCO® SpMet® SpO2 Adult Reusable Sensor	2696	FDA UDI	Class II	Active
Rad-G	9847	FDA UDI	Class II	Active
Rad-8 Horizontal signal extraction pulse oximeter	3446	FDA UDI	Class II	Active
RD SET™ Training Kit	4201	FDA UDI	Class II	Active
Emma™	mmHg	FDA UDI	Class II	Active
Stork	95082	FDA UDI	Class II	Active
NomoLine	4990	FDA UDI	Class I	Active
MasimoSET® LNCS® NeoPt Neonatal Pulse Oximeter Adhesive Sensor	2330	FDA UDI	Class II	Active
LNCS® Sensor Training Kit	2345	FDA UDI	Class II	Active
LNCS SpO2	4869	FDA UDI	Class II	Active
NomoLine™ LH Infant/Neonatal Airway Adapter Set	4369	FDA UDI	Class II	Active
Isa™ Or+	OR+ LEMO	FDA UDI	Class II	Active
Masimo W1	95080-105	FDA UDI	Class II	Active
DCIP SC 200 200 spot checks Pediatric/Slender digit Reusable Sensor	3419	FDA UDI	Class II	Active
RD rainbow SET™ R25-05 RD rainbow SET Series Patient Cable	4076	FDA UDI	Class II	Active
NomoLine™ LH Adult Nasal/Oral CO2 Cannula with O2	3824	FDA UDI	Class II	Active
MasimoSET uSpO2 Masimo SET Oximetry Cable, USB signal extraction pulse oximeter	3412	FDA UDI	Class II	Active
O3™ Sensor rSO2 SpO2 Medium Adhesive Sensor	4193	FDA UDI	Class II	Active
ReSposable™ S-DOS™ 20L SpO2 Infant Pulse Oximeter Disposable Optical Sensor	2470	FDA UDI	Class II	Active
MightySat	9956	FDA UDI	Class II	Active
Nomoline	4410	FDA UDI	Class II	Active
LiDCO	95098	FDA UDI	Class II	Active
O3	4315	FDA UDI	Class II	Active
rainbow ReSposable, R2-25a, Adult Pulse CO-Oximeter Disposable Optical Sensor	2753	FDA UDI	Class II	Active
Opioid Halo	4724	FDA UDI	Class II	Unknown
03 Sensor rS02 Large Adhesive Sensor	3756	FDA UDI	Class II	Active
MasimoSET LNC-MAC-GE LNCS® to GE Adapter Cable	2264	FDA UDI	Class II	Active
SedLine™ EEG Sensor	2479	FDA UDI	Class II	Active
Rad-8 Horizontal Signal Extraction Pulse Oximeter	9190	FDA UDI	Class II	Active
M-LNCS™ Sensor Training Kit	2659	FDA UDI	Class II	Active
Iris Adapter, Ventilator, Viasys, LTV1200	3713	FDA UDI	Class II	Active
MasimoSET® LNOP® Newborn SpO2 Neonatal Pulse Oximeter Adhesive Sensor	2203	FDA UDI	Class II	Active
Radius PPG	4584	FDA UDI	Class II	Active
MasimoSET Red LNC-10 LNCS® Patient Cable	2056	FDA UDI	Class II	Active
MasimoSET® LNCS® TF-I SpO2 Reusable Forehead Sensor	1896	EUDAMEDFDA UDI	Class II	Active
Radius-7	9837	FDA UDI	Class II	Active
Nomoline™ Nomo Extension	Nomo Extension 3m	FDA UDI	Class I	Unknown
MasimoSET® M-LNCS™ Newborn SpO2 Neonatal Pulse Oximeter Adhesive Sensor	2519	FDA UDI	Class II	Active
MasimoSET LNCS® TC-I SpO2 Reusable Ear Sensor	1895	EUDAMEDFDA 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.