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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 10 of 21

Device	Model / Reference	Registries	Class	Status
MasimoSET LNC-10 LNCS® Series Patient Cable	1814	FDA UDI	Class II	Active
Radius VSM	9033	FDA UDI	Class II	Active
Radius-7	9664	FDA UDI	Class II	Active
R2-25r SpHb SpO2 SpMet Adult Pulse CO-Oximeter Reusable Optical Sensor (ROS)	3395	FDA UDI	Class II	Active
Rd Set	4479	FDA UDI	Class II	Active
NomoLine™ LH Adult Nasal CO2 Cannula 4m	4622	FDA UDI	Class I	Active
NomoLine-O™ LH Pediatric Nasal/Oral CO2 Cannula with O2 4m	4639	FDA UDI	Class I	Active
Rd Set	4474	FDA UDI	Class II	Active
NomoLine™ HH Multi-Patient Use Adapter	3800	FDA UDI	Class II	Active
rainbow	4483	FDA UDI	Class II	Active
Rad-5v™ Handheld signal extraction pulse oximeter	9199	FDA UDI	Class II	Active
NomoLine-O HH Adult/Pediatric Airway Adapter Set	4449	FDA UDI	Class II	Active
MasimoSET LNCS® DCI-P SpO2 Pediatric/Slender digit Reusable Finger Clip Sensor	1864	EUDAMEDFDA UDI	Class II	Active
Pronto™ Pulse CO-Oximeter™	9186	FDA UDI	Class II	Active
SpO2.COM® RS-1 adult SpO2 reusable sensor	1778	FDA UDI	Class II	Active
RD SET™ MD20-05 RD SET Series Patient Cable	4103	FDA UDI	Class II	Active
uSpO2	3849	FDA UDI	Class II	Active
O3	4616	FDA UDI	Class II	Active
Rad-97	9797	EUDAMEDFDA UDI	Class II	Active
Rd Set	4478	FDA UDI	Class II	Active
MasimoSET® rainbow® RC25-1 rainbow® Patient Cable	3933	FDA UDI	Class II	Active
MasimoSET® M-LNCS® Patient Cable Red LNCv-4	3513	FDA UDI	Class II	Active
MasimoSET® Red PC-08 LNOP® SpO2 Patient Cable	2059	FDA UDI	Class II	Active
LNCS® Neo Sample Pack	2348	FDA UDI	Class II	Active
RD SET Rad-G-12	4774	FDA UDI	Class II	Active
Masimo W1	95080	FDA UDI	Class II	Active
NomoLine-O HH Pediatric Nasal/Oral CO2 Cannula with O2	4647	FDA UDI	Class I	Active
NomoLine™ Infant/Neonatal Airway Adapter Set with Luer	4368	FDA UDI	Class II	Active
MasimoSET® LNOP® Neo SpO2 Neonatal Pulse Oximeter Adhesive Sensor	1002	FDA UDI	Class II	Active
RD SpO2	4867	FDA UDI	Class II	Active
MasimoSET® Accessory Adhesive Squares	1600	FDA UDI	Class II	Active
MasimoSET® M-LNCS™ Blue® SpO2 Cyanotic Pulse Oximeter Adhesive Sensor	2522	FDA UDI	Class II	Active
SatShare™ Interface D006 Cable	2223	FDA UDI	Class II	Active
MasimoSET® LNOP® Adtx SpO2 Adult Pulse Oximeter Adhesive Sensor	1829	FDA UDI	Class II	Active
LNOP® Sensor Sample Pack	2262	FDA UDI	Class II	Active
Rad-67	9794	FDA UDI	Class II	Active
SpO2.COM® Infant SpO2 disposable sensor	1777	FDA UDI	Class II	Active
DCSC SpO2 Adult Reusable Sensor	1396	FDA UDI	Class II	Active
MasimoSET® M-LNC-1 M-LNCS™ Series Patient Cable	2523	FDA UDI	Class II	Active
MasimoSET® PC08 LNOP® Series Patient Cable	1005	FDA UDI	Class II	Active
SatShare™ Extension Cable EX01	1605	FDA UDI	Class II	Active
Radius VSM	9036	FDA UDI	Class II	Active
RD SET™ GE-12 RD SET to GE Patient Cable	4085	FDA UDI	Class II	Active
Stork	95083	FDA UDI	Class II	Active
MasimoSET® MAC-1 LNOP® SpO2 Patient Cable	1927	FDA UDI	Class II	Active
MasimoSET® uSpO2™ Masimo SET Oximetry Cable, UT	3315	FDA UDI	Class II	Active
Irma™ Ax+	4768	FDA UDI	Class II	Active
MasimoSET® rainbow Replacement Tapes	2323	FDA UDI	Class II	Active
MasimoSET® M-LNCS™ Inf-3 SpO2 Infant Pulse Oximeter Adhesive Sensor	2513	FDA UDI	Class II	Active
Masimo W1	95080-500	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

MDSS GmbH DE

Importers

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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.