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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 1 of 21

Device	Model / Reference	Registries	Class	Status
LNCS Red TFA-1	3857	EUDAMED	Class IIb	Active
NomoLine™ LH Pediatric Nasal/Oral CO2 Cannula with O2	3825	FDA UDI	Class II	Active
Adult/Pediatric Adhesive Sensors	1228	FDA UDI	Class II	Active
NomoLine-O™ LH Adult Nasal CO2 Cannula with O2 4m	4634	FDA UDI	Class I	Active
NomoLine-O™ LH Adult/Pediatric Airway Adapter Set 4m	4630	FDA UDI	Class I	Active
MightySat™ Rx Fingertip Pulse Oximeter	9907	FDA UDI	Class II	Active
M-LNCS™ Inf-L Infant Pulse Oximeter Adhesive Sensor	3670	FDA UDI	Class II	Active
Lncs	2691	FDA UDI	Class II	Active
Radius VSM	4828	FDA UDI	Class II	Active
LNCS® Inf-L SpO2 Infant Pulse Oximeter Adhesive Sensor	1861	EUDAMEDFDA UDI	Class II	Active
Radius PPG	9955	FDA UDI	Class II	Active
GE Carescape Sp02 - Masimo rainbow SET Pulse CO-Oximetry Module	4184	FDA UDI	Class II	Active
rainbow	4484	FDA UDI	Class II	Active
Rd-Set	4675	FDA UDI	Class II	Active
Radius T	4823	FDA UDI	Class II	Active
LNCS Inf-L infant SpO2 adhesive sensor	2828-5	FDA UDI	Class II	Active
MasimoSET® LNOP® TC-I SpO2 Reusable Ear Sensor	1794	FDA UDI	Class II	Active
MasimoSET® M-LNCS™ DCIv adult SpO2 reusable sensor	3505	FDA UDI	Class II	Active
rainbow®R20L SpCO® SpO2 SpMet® Infant Pulse CO-Oximeter® Adhesive Sensor	2220	FDA UDI	Class II	Active
Pronto™ Pulse CO-Oximeter®	4175	FDA UDI	Class II	Active
MasimoSET® LNOP® Newborn SpO2 Infant/Pediatric Pulse Oximeter Adhesive Sensor	2204	FDA UDI	Class II	Active
Isa™ Co2	CO2	FDA UDI	Class II	Active
EMMA™ Capnometer Kit	kPa	FDA UDI	N/A	Unknown
Rd Set	4003	FDA UDI	Class II	Active
MasimoSET® M-LNC™-MAC-GE M-LNCS™ to GE Adapter Cable	2540	FDA UDI	Class II	Active
MasimoSET® Foam Wrap	1602	FDA UDI	Class II	Active
MasimoSET® Red DBI-dc8 SpO2 Adult Reusable Sensor	2644	FDA UDI	Class II	Active
MasimoSET® LNC MP10 LNCS® to IVM/MMS	2281	FDA UDI	Class II	Active
O3	4431	FDA UDI	Class II	Active
RD rainbow SET™ RA25-08 RD rainbow SET Series Patient Cable	4107	FDA UDI	Class II	Active
MasimoSET® Rainbow Adult Sensor Sample Pack	2291	FDA UDI	Class II	Active
Rad-5v™ Handheld signal extraction pulse oximeter	9711	FDA UDI	Class II	Active
NomoLine-O HH Infant Airway Adapter Set	4450	FDA UDI	Class II	Active
NomoLine™ HH Adult Nasal CO2 Cannula	3830	FDA UDI	Class II	Active
Irma™ Co2	4748	FDA UDI	Class II	Active
MasimoSET® rainbow® RC25-12 rainbow® Patient Cable	3342	FDA UDI	Class II	Active
Radius T	4779	FDA UDI	Class II	Active
MasimoSET Red 25 LNC-4RA LNCS® Patient Cable for SpO2	3376	FDA UDI	Class II	Active
NomoLine™ LH Pediatric Nasal/Oral CO2 Cannula 4m	4627	FDA UDI	Class I	Active
RD SET NeoPt-500 SpO2, PR, PI, PVI Neonatal Pulse Oximeter Non-Adhesive Sensor	4005	FDA UDI	Class II	Active
NomoLine-O™ LH Adult Single Nasal Prong CO2 Cannula	4663	FDA UDI	Class I	Active
MasimoSET® M-LNCS™ TC-I SpO2 Reusable Ear Sensor	2503	FDA UDI	Class II	Active
Nomoline	4833	FDA UDI	Class I	Active
Nomoline	4427	FDA UDI	Class II	Active
MightySat	9941	FDA UDI	Class II	Active
rainbow	4481	FDA UDI	Class II	Active
SatShare™ Interface AT01 Cable	1595	FDA UDI	Class II	Active
NomoLine™ Comfort HH Adult Nasal CO2 Cannula with O2	4733	FDA UDI	Class II	Active
rainbow Replacement Tapes, R/R1 20L	2624	FDA UDI	Class II	Active
Masimo Ambient Shield Accessory	2815	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

MDSS GmbH DE

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Authorities

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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.