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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 17 of 21

Device	Model / Reference	Registries	Class	Status
MasimoSET® M-LNC™ MAC-SL2 M-LNCS™ to Spacelabs Adapter Cable	2542	FDA UDI	Class II	Active
Rad-97	95004	FDA UDI	Class II	Active
Radical-7™ Color Screen Handheld signal extraction pulse co-oximeter®	9086	FDA UDI	Class II	Active
MasimoSET® IntelliVue Module signal extraction pulse oximeter	3924	FDA UDI	Class II	Active
MasimoSET LNCS® Multisite-L reusable sensor	2192	FDA UDI	Class II	Active
RAD-57cm™ Pulse CO-Oximeter™	9062	FDA UDI	Class II	Active
MasimoSET® LNCS® DCIv adult SpO2 Reusable Sensor	2924	FDA UDI	Class II	Active
LNCS NeoPt-500 Non-Adhesive Sensor	2331	FDA UDI	Class II	Active
M-LNCS™ Neo SpO2 Neonatal/Adult Pulse Oximeter Adhesive Sensor	2514	FDA UDI	Class II	Active
ReSposable™ S-DOS™ 25 SpO2 Adult Pulse Oximeter Disposable Optical Sensor	2434	FDA UDI	Class II	Active
RD SET™ Pdt SpO2, PR, PI, PVI® Pediatric Pulse Oximeter Adhesive Sensor	4001	FDA UDI	Class II	Active
MasimoSET® M-LNCS™ to PC Adapter Cable M-LNCS™ to LNOP® PC Patient Cable	2858	FDA UDI	Class II	Active
Rad-5® Handheld signal extraction pulse oximeter	9198	FDA UDI	Class II	Active
MasimoSET Red LNC-14 LNCS® Patient Cable	2057	FDA UDI	Class II	Active
Rd Set	4617	FDA UDI	Class II	Active
NomoLine™ LH Pediatric Nasal CO2 Cannula	3818	FDA UDI	Class II	Active
NomoLine-O LH Adult Nasal/Oral CO2 Cannula with O2	4459	FDA UDI	Class II	Active
MasimoSET Red LNC-01 LNCS® Patient Cable	2365	FDA UDI	Class II	Active
RD SET™ DCI SpO2 Adult Reusable Finger Clip Sensor	4050	FDA UDI	Class II	Active
Radius-7	9916	FDA UDI	Class II	Active
rainbow® M20-04, rainbow® Patient Cable	4237	FDA UDI	Class II	Active
Irma™ Co2	4749	FDA UDI	Class II	Active
Lncs	2692	FDA UDI	Class II	Active
SpO2.COM® NRC-SL2 Spacelabs Replacement Cable	2335	FDA UDI	Class II	Active
RD rainbow	4035	FDA UDI	Class II	Active
MasimoSET® SofTouch™ Replacement Wraps	2322	FDA UDI	Class II	Active
RD SedLine	4248	FDA UDI	Class II	Active
ReSposable S-DOS 25LSpO2 Neonatal/Adult Pulse Oximeter Disposable Optical Sensor	2469	FDA UDI	Class II	Active
MasimoSET® LNC-4-EXT LNC Extension Cable	2021	FDA UDI	Class II	Active
Rad-57cm™ Pulse CO-Oximeter™	9180	FDA UDI	Class II	Active
MasimoSET® PC SL-12 LNOP® to Spacelabs Patient Cable	2433	FDA UDI	Class II	Active
Radical Docking Station RDS-3 signal extraction pulse oximeter	9023	FDA UDI	Class II	Active
MasimoSET® transflectance sensor adhesive pads	1833	FDA UDI	Class II	Active
NomoLine™ HH Adult Nasal/Oral CO2 Cannula with O2	3837	FDA UDI	Class II	Active
MasimoSET® MAC-1 LNOP® to LNC Adapter Cable	1645	FDA UDI	Class II	Active
MasimoSET® Standard Multisite Wrap	1597	FDA UDI	Class II	Active
MasimoSET® ReSposable™ Replacement Tapes for S-DOS™ 20L/25L/30L Sensors	3439	FDA UDI	Class II	Active
Radius PCG™	EMMA Bluetooth mmHg	FDA UDI	Class II	Active
RAD-57c™ Pulse CO-Oximeter™	9076	FDA UDI	Class II	Active
MasimoSET® M-LNCS™ E1™ SpO2 Adult Single-Patient Use Ear Sensor	2919	FDA UDI	Class II	Active
Home Health Kit	99042	FDA UDI	Class II	Active
MasimoSET M-LNCS Multisite-L Reusable Sensor	2506	FDA UDI	Class II	Active
LNCS NeoL SpO2 Neonatal/Adult Pulse Oximeter Adhesive Sensor	2830-5	FDA UDI	Class II	Active
NomoLine-O HH Adult Nasal CO2 Cannula	4643	FDA UDI	Class I	Active
rainbow® R1 20L SpHb® SpO2 SpMet® Infant CO-Oximeter® Adhesive Sensor	2415	FDA UDI	Class II	Active
Emma™	kPa	FDA UDI	Class II	Active
MasimoSET® LNOP® TF-I SpO2 Adult Reusable Forehead Sensor	1793	FDA UDI	Class II	Active
MasimoSET® LNCS® NeoPt-500 SpO2 Neonatal Pulse Oximeter Non-Adhesive Sensor	2606	FDA UDI	Class II	Active
MasimoSET® M-LNC-04-DB9 M-LNCS™ to DB9 Patient Cable	2534	FDA UDI	Class II	Active
R1 25 SpHb® SpO2, SpMet® Adult Pulse Co-Oximeter® Adhesive Sensor	3792	FDA UDI	Class II	Active

Related Companies

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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.