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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 14 of 21

Device	Model / Reference	Registries	Class	Status
Nomoline	5301	FDA UDI	Class II	Active
RD SET™ MD14-12 RD SET Series Patient Cable	4081	FDA UDI	Class II	Active
RD rainbow	4691	FDA UDI	Class II	Active
Rainbow® DCI® SC 1000 SpHb® SpO2 SpMet® 1000 spot checks Adult Reusable Sensor	3647	FDA UDI	Class II	Active
M-LNCS INF-3, infant SpO2 adhesive sensor	2912-5	EUDAMEDFDA UDI	Class II	Active
Masimo W1	95080-102	FDA UDI	Class II	Active
EMMA™ Capnometer Kit	mmHg	FDA UDI	N/A	Unknown
Rd Set	4001	FDA UDI	Class II	Active
NomoLine-O	4969	FDA UDI	Class II	Active
RD SET™ NeoPt SpO2, PR, PI, PVI® Neonatal Pulse Oximeter Adhesive Sensor	4004	FDA UDI	Class II	Active
ProCal+™ CBL MASIMO INT SpO2 1.5M	1872	FDA UDI	Class II	Active
MightySat™ Rx Fingertip Pulse Oximeter	9809	FDA UDI	Class II	Active
EMMA™ Airway Adapter	17448	FDA UDI	Class I	Active
RD rainbow	4693	FDA UDI	Class II	Active
O3	4496	FDA UDI	Class II	Active
Rad-57™ Pulse CO-Oximeter™	9216	FDA UDI	Class II	Active
Radius PCG™ Kit	9961	FDA UDI	Class II	Active
NomoLine™ HH Infant Nasal CO2 Cannula	3832	FDA UDI	Class II	Active
MightySat Medical	5356	FDA UDI	Class II	Active
Radical-7®	9500	FDA UDI	Class II	Active
M-LNCS™ Neo-3 SpO2 Neonatal/Adult Pulse Oximeter Adhesive Sensor	2515	FDA UDI	Class II	Active
RAS-125c short term monitoring acoustic respiration cloth sensor	3401	FDA UDI	Class II	Active
rainbow® DCI-dc12 SpCO® SpMet® SpO2 Adult Direct Connect Reusable Sensor	2202	FDA UDI	Class II	Active
NomoLine™ Comfort HH Adult Nasal/Oral CO2 Cannula with O2	4734	FDA UDI	Class II	Active
SatShare Cable, DO02	1326	FDA UDI	Class II	Active
NomoLine™ LH Adult Nasal/Oral CO2 Cannula 4m	4626	FDA UDI	Class I	Active
MasimoSET® LNCS® Pdtx-3 SpO2 Pediatric Pulse Oximeter Adhesive Sensor	2602	FDA UDI	Class II	Active
uSpO2™ Masimo Set Oximetry Cable, UT	4209	FDA UDI	Class II	Active
Nomoline™ T-adapter	T-adapter	FDA UDI	Class I	Unknown
Pronto™ Pulse CO-Oximeter®	9167	FDA UDI	Class II	Active
Radius VSM	9034	FDA UDI	Class II	Active
uSpO2 Pulse Oximetry Cable for GE ApexPro® FH with LNCS® Sensor Sample Pack	3636	FDA UDI	Class II	Active
Rad-5v™ Handheld signal extraction pulse oximeter	9235	FDA UDI	Class II	Active
NomoLine™ HH Pediatric Nasal/Oral CO2 Cannula	3836	FDA UDI	Class II	Active
R1 20 Pediatric/Slender digit Pulse Co-Oximeter® Adhesive Sensor	3793	FDA UDI	Class II	Active
Rd Set	4471	FDA UDI	Class II	Active
Radius-7	9914	FDA UDI	Class II	Active
Patient SafetyNet Console	25377	FDA UDI	Class II	Active
Nomoline	4595	FDA UDI	Class II	Active
Radius-7	4547	FDA UDI	Class II	Active
rainbow® DCI-dc3 SpCO® SpMet® SpO2 Adult Direct Connect Reusable Sensor	2201	FDA UDI	Class II	Active
NomoLine™ HH Adult/Pediatric Airway Adapter Set	3827	FDA UDI	Class II	Active
Masimo W1	95080-101	FDA UDI	Class II	Active
LNCS® Adtx/Pdtx Sample Pack	1897	FDA UDI	Class II	Active
DCIP-dc8 SpCO SpMet SpO2 Pediatric/Slender digit Direct Connect Reusable Sensor	2640	FDA UDI	Class II	Active
NomoLine™ Infant Airway Adapter Set with Luer	3803	FDA UDI	Class II	Active
RD rainbow	4037	FDA UDI	Class II	Active
MightySat	4928	FDA UDI	Class II	Active
Rd Set	4053	FDA UDI	Class II	Active
RD rainbow	4692	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

MDSS GmbH DE

Importers

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Notified Bodies

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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.