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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 9 of 21

Device	Model / Reference	Registries	Class	Status
Masimo SET	4321	FDA UDI	Class II	Active
MasimoSET® LNOP® Pdt SpO2 Pediatric Pulse Oximeter Adhesive Sensor	1025	FDA UDI	Class II	Active
MasimoSET® Replacement Wraps for LNOP® NeoPt Sensors	1053	FDA UDI	Class II	Active
MasimoSET® M-LNC™ MAC-395 M-LNCS™ to N-395 Adapter Cable	2538	FDA UDI	Class II	Active
NomoLine™ LH Adult/Pediatric Airway Adapter Set 3m	3815	FDA UDI	Class II	Active
NomoLine™ Adult/Pediatric Airway Adapter Set with Luer	3801	FDA UDI	Class II	Active
MasimoSET® RC25-4 rainbow® Patient Cable	3628	FDA UDI	Class II	Active
NomoLine-O HH Pediatric Nasal CO2 Cannula with O2	4645	FDA UDI	Class I	Active
MasimoSET® LNCS® Patient Cable Red LNCv-10	3512	FDA UDI	Class II	Active
MasimoSET LNC-MAC-SL LNCS® to Spacelabs Adapter Cable	2266	FDA UDI	Class II	Active
Rad-97	9802	FDA UDI	Class II	Active
NomoLine™ Training Kit	4381	FDA UDI	Class II	Active
MasimoSET® LNOP® NeoPt-L SpO2 Neonatal Pulse Oximeter Adhesive Sensor	1651	FDA UDI	Class II	Active
SpO2.COM® NRC-395 Patient Cable	1811	FDA UDI	Class II	Active
MasimoSET® M-LNCS™ Trauma SpO2 Adult Pulse Oximeter Adhesive Sensor	2521	FDA UDI	Class II	Active
Radius-PPG	4586	FDA UDI	Class II	Active
MasimoSET® IntelliVue Module signal extraction pulse oximeter	3914	FDA UDI	Class II	Active
DCIP-dc3 SpCO SpMet® SpO2 Pediatric/Slender digit Direct Connect Reusable Sensor	2069	FDA UDI	Class II	Active
Rad-5v™ Handheld signal extraction pulse oximeter	9540	FDA UDI	Class II	Active
NomoLine™ Pediatric Nasal CO2 Cannula with Luer	3805	FDA UDI	Class II	Active
O3	4273	FDA UDI	Class II	Active
Radius PCG™ Kit	9962	FDA UDI	Class II	Active
MasimoSET LNCS® E1™ SpO2 Adult Pulse Oximeter Adhesive Sensor	2918	EUDAMEDFDA UDI	Class II	Active
Rad-G	9895	FDA UDI	Class II	Active
MasimoSET® LNCS® Newborn SpO2 Neonatal Pulse Oximeter Adhesive Sensor	2412	EUDAMEDFDA UDI	Class II	Active
M-LNCS Neo SpO2 Neonatal/Adult Pulse Oximeter Adhesive Sensor	2913-5	FDA UDI	Class II	Active
Rad-8® Horizontal signal extraction pulse oximeter	9174	FDA UDI	Class II	Active
NomoLine	4416	FDA UDI	Class II	Active
LNCS® Adult Sample Pack	2347	FDA UDI	Class II	Active
MasimoSET® LNCS® Pdtx Pediatric Pulse Oximeter Adhesive Sensor	2318	EUDAMEDFDA UDI	Class II	Active
MasimoSET® PC-4-GE LNOP® to GE Patient Cable	3667	FDA UDI	Class II	Active
Soft Wrap Armband	3444	FDA UDI	Class II	Active
uSpO2™ Masimo Set Oximetry Cable, UT	4210	FDA UDI	Class II	Active
RAS-45 RRa Adult/Pediatric Acoustic Respiration Sensor	4171	FDA UDI	Class II	Active
MasimoSET® rainbow RC-1 rainbow® Patient Cable	2405	FDA UDI	Class II	Active
rainbow ReSposable Pulse CO-Oximeter Sensor System, Adult	3457	FDA UDI	Class II	Active
rainbow	3797	FDA UDI	Class II	Active
Accessory clothing clips	1601	FDA UDI	Class II	Active
Ras-45	4533	FDA UDI	Class II	Active
uSpO2Pulse Oximetry Cable with LNCS Sensor Sample Pack	3635	FDA UDI	Class II	Active
RAS-125c, Adult/Ped Short Term Monitoring, Acoustic Respiration Cloth Sensor	3483	FDA UDI	Class II	Active
Pronto-7™ Spot Check Pulse CO-Oximeter	9221	FDA UDI	Class II	Active
MasimoSET® LNCS® NeoPt-3 SpO2 Neonatal Pulse Oximeter Adhesive Sensor	2605	FDA UDI	Class II	Active
Radical Docking Station RDS-3 signal extraction pulse oximeter	9172	FDA UDI	Class II	Active
iSpO2, Large, Consumer, Lightning	9573	FDA UDI	Class II	Active
MasimoSET® LNOP® Trauma SpO2 Adult Pulse Oximeter Adhesive Sensor	2358	FDA UDI	Class II	Active
MasimoSET® rainbow® RC25-12RA rainbow® Patient Cable	3343	FDA UDI	Class II	Active
M-LNCS to LNC MAC Adapter Cable M-LNCS to LNC MAC Spacelabs Patient Cable	2750	FDA UDI	Class II	Active
MasimoSET® M-LNCS™ Pdtx SpO2 Pediatric Pulse Oximeter Adhesive Sensor	2510	FDA UDI	Class II	Active
Root	9904	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.