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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 6 of 21

Device	Model / Reference	Registries	Class	Status
ProCal+ CBL MASIMO INT SpO2 2M	2353	FDA UDI	Class II	Active
4D DC Sensor, Small	9400	FDA UDI	Class II	Active
LNCS-II rainbow	4060	FDA UDI	Class II	Active
MasimoSET® M-LNCS™ DCI-Pv pediatric/slender digit SpO2 reusable sensor	3506	FDA UDI	Class II	Active
MasimoSET DBI-dc3 SpO2 Adult Reusable Sensor	2651	FDA UDI	Class II	Active
RD rainbow SET™ RA25-12 RD rainbow SET Series Patient Cable	4079	FDA UDI	Class II	Active
MasimoSET Reprocessed LNCS® Pdtx SpO2 Pediatric Pulse Oximeter Adhesive Sensor	2688	FDA UDI	Class II	Active
Masimo W1	95080-108	FDA UDI	Class II	Active
rainbow® DCIP SpCO® SpMet® SpO2 Pediatric/Slender digit Reusable Sensor	2697	FDA UDI	Class II	Active
Radical Docking Station RDS-2 signal extraction pulse oximeter	9022	FDA UDI	Class II	Active
MasimoSET® Rainbow Ped/Inf Sensor Sample Pack	2292	FDA UDI	Class II	Active
MasimoSET® LNC-04-DB9 LNCS® to DB9 Patient Cable	2285	FDA UDI	Class II	Active
NomoLine™ Pediatric Nasal/Oral CO2 Cannula with Luer	3810	FDA UDI	Class II	Active
SpO2.COM® NRC-SL Spacelabs Replacement Cable	1900	FDA UDI	Class II	Active
NomoLine-O™ LH Pediatric Nasal CO2 Cannula with O2 4m	4635	FDA UDI	Class I	Active
SofTouch Replacement Wraps for RD SET NeoPt-500	4094	FDA UDI	Class II	Active
RAD-8® LNCS® Neo Sample Pack	3381	FDA UDI	Class II	Active
NomoLine-O™ LH Pediatric Nasal CO2 Cannula 4m	4633	FDA UDI	Class I	Active
Rad-57™ Pulse CO-Oximeter™	3726	FDA UDI	Class II	Active
M-LNCS Pdtx-3 SpO2 Pediatric Pulse-Ox Adhesive Sensor	2910-5	FDA UDI	Class II	Active
MasimoSET DC-8 SpO2 Adult Reusable Sensor	2387	FDA UDI	Class II	Active
MasimoSET® M-LNCS® Patient Cable M-LNCv- 4	3509	FDA UDI	Class II	Active
Radical-7™ Color Screen Handheld signal extraction pulse co-oximeter®	9178	FDA UDI	Class II	Active
Lncs	5265	EUDAMEDFDA UDI	Class II	Active
Radius PPG	4778	FDA UDI	Class II	Active
O3	4384	FDA UDI	Class II	Active
Masimo SET	4320	FDA UDI	Class II	Active
MasimoSET® LNCS® Neo Neonatal/Adult Pulse Oximeter Adhesive Sensor	2329	FDA UDI	Class II	Active
Rd Set	4477	FDA UDI	Class II	Active
NomoLine™ Pediatric Nasal/Oral CO2 Cannula with O2 and Luer	3812	FDA UDI	Class II	Active
RD rainbow	4034	FDA UDI	Class II	Active
MasimoSET® M-LNC-4-GE M-LNCS™ to GE Patient Cable	2655	FDA UDI	Class II	Active
RD SpO2	4866	FDA UDI	Class II	Active
rainbow® R20 SpCO® SpO2 SpMet® Pediatric Pulse CO-Oximeter® Adhesive Sensor	2222	FDA UDI	Class II	Active
Lncs	3858	EUDAMEDFDA UDI	Class II	Active
SatShare™ Interface SM01 Cable	1322	FDA UDI	Class II	Active
Stork	95094	FDA UDI	Class II	Active
LNCS® Neo-L SpO2 Neonatal/Adult Pulse Oximeter Adhesive Sensor	1862	FDA UDI	Class II	Active
Irma™ Co2	4750	FDA UDI	Class II	Active
ReSposable™ S-DOS™ 20 SpO2 Pediatric Pulse Oximeter Disposable Optical Sensor	2435	FDA UDI	Class II	Active
Radical Docking Station RDS-3 signal extraction pulse oximeter	9171	FDA UDI	Class II	Active
Rd Set	4052	FDA UDI	Class II	Active
SpO2.COM® adult/neonatal SpO2 disposable sensor	1776	FDA UDI	Class II	Active
Rad-8 Vertical Signal Extraction Pulse Oximeter	9219	FDA UDI	Class II	Active
SatShare™ Interface NK02 Cable	1368	FDA UDI	Class II	Active
MasimoSET® Red PC-12 LNOP® SpO2 Patient Cable	2060	FDA UDI	Class II	Active
NomoLine™ LH Infant Airway Adapter Set	3816	FDA UDI	Class II	Active
MasimoSET LNCS® YI SpO2 Multisite Reusable Sensor	2258	EUDAMEDFDA UDI	Class II	Active
RD rainbow	5306	FDA UDI	Class II	Active
Irma™ Co2	CO2 Breas	FDA UDI	Class II	Active

Related Companies

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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.