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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 18 of 21

Device	Model / Reference	Registries	Class	Status
RD rainbow SET	4279	FDA UDI	Class II	Active
MasimoSET® M-LNCS™ Inf SpO2 Infant Pulse Oximeter Adhesive Sensor	2512	FDA UDI	Class II	Active
DCP-3 SC 200 Pediatric/Slender Digit Reusable Sensor	2647	FDA UDI	Class II	Active
RD rainbow SET-2	4029	FDA UDI	Class II	Active
NomoLine™ Adult Nasal/Oral CO2 Cannula with Luer	3809	FDA UDI	Class II	Active
MasimoSET® Red DCI-dc3 SpO2 Adult Reusable Sensor	2053	FDA UDI	Class II	Active
MasimoSET® Masimo Headband	2215	FDA UDI	Class II	Active
MasimoSET® LNCS® Patient Cable Red LNCv-4	3511	FDA UDI	Class II	Active
MasimoSET LNC-01 LNCS® Series Patient Cable	2364	FDA UDI	Class II	Active
MasimoSET® M-LNCS® to LNC Adapter Cable	2654	FDA UDI	Class II	Active
MasimoSET® IntelliVue Module signal extraction pulse oximeter	3915	FDA UDI	Class II	Active
MasimoSET LNC-MAC-180 LNCS® Series to N-180 Adapter Cable	2268	FDA UDI	Class II	Active
RD rainbow SET RAM	4512	FDA UDI	Class II	Active
NomoLine-O HH Adult Nasal CO2 Cannula with O2	4451	FDA UDI	Class II	Active
NomoLine™ LH Adult Nasal/Oral CO2 Cannula	3822	FDA UDI	Class II	Active
SatShare™ Interface SL02 Cable	1362	FDA UDI	Class II	Active
Large Radius-7™ Arm Band	37099	FDA UDI	Class II	Active
MasimoSET rainbow® RC25-4RA rainbow® Patient Cable	3375	FDA UDI	Class II	Active
Lncs-Ii	4058	FDA UDI	Class II	Active
LNOP® INF-L infant SpO2 adhesive sensor	1968	FDA UDI	Class II	Active
Patient SafetyNet Console	25376	FDA UDI	Class II	Active
MasimoSET® PC04-EXT LNOP® Extension Cable	1619	FDA UDI	Class II	Active
NomoLine™ LH Adult/Pediatric Airway Adapter Set	3814	FDA UDI	Class II	Active
Rad-57™ Pulse CO-Oximeter™	3737	FDA UDI	Class II	Active
SpO2.COM® NRC-P8 Patient Cable, 3M	1949	FDA UDI	Class II	Active
MasimoSET® LNOP® Inf-L SpO2 Infant Pulse Oximeter Adhesive Sensor	1800	FDA UDI	Class II	Active
Masimo rainbow SET RAM Dual Cable, RC25-10	3503	FDA UDI	Class II	Active
MasimoSET Red MNC Adapter Cable	2641	FDA UDI	Class II	Active
Rad-5v™ Handheld signal extraction pulse oximeter	9215	FDA UDI	Class II	Active
Resposable S-DOS 20L-500 Neonatal Pulse Oximeter Non-Adhesive Disposable Sensor	2477	FDA UDI	Class II	Active
LNCS-II rainbow	4061	FDA UDI	Class II	Active
LNCS® Pdtx SpO2 Pediatric Pulse Oximeter Adhesive Sensor	1860	EUDAMEDFDA UDI	Class II	Active
MasimoSET® Red DCIP-dc3 SpO2 Pediatric Reusable Sensor	2256	FDA UDI	Class II	Active
MasimoSET LNC-10-GE LNCS® to GE Patient Cable	2016	FDA UDI	Class II	Active
NomoLine-O™ LH Infant Nasal CO2 Cannula	4662	FDA UDI	Class I	Active
RD SET™ Inf SpO2, PR, PI, PVI® Infant Pulse Oximeter Adhesive Sensor	4002	FDA UDI	Class II	Active
NomoLine-O™ LH Pediatric Nasal CO2 Cannula	4641	FDA UDI	Class I	Active
SofTouch Replacement Wraps for RD SET NeoPt	4048	FDA UDI	Class II	Active
Isa™ Co2	CO2	FDA UDI	Class II	Active
MasimoSET® M-LNC™ MAC-SL M-LNCS™ to Spacelabs Adapter Cable	2541	FDA UDI	Class II	Active
RD rainbow SET™ R25-12 RD rainbow SET Series Patient Cable	4078	FDA UDI	Class II	Active
MasimoSET® PC-8-GE LNOP® to GE Patient Cable	3666	FDA UDI	Class II	Active
MasimoSET® LNCS® Neo Neonatal/Adult Pulse Oximeter Adhesive Sensor	2320	EUDAMEDFDA UDI	Class II	Active
RD SET™ Adt SpO2, PR, PI, PVI® Adult Pulse Oximeter Adhesive Sensor	4000	FDA UDI	Class II	Active
SpO2.COM® adult SpO2 disposable sensor	1774	FDA UDI	Class II	Active
MasimoSET LNC-04 LNCS® Series Patient Cable	2017	FDA UDI	Class II	Active
Rad-87™ Horizontal signal extraction pulse co-oximeter®	9284	FDA UDI	Class II	Active
Masimo Root Monitoring System and Accessories	K153225	FDA 510(k)	Class II	Active
Masimo Set Radical 7 Pulse Co-Oximeter	K061204	FDA 510(k)	Class II	Active
Masimo Root Monitoring System	K140188	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

MDSS GmbH DE

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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.