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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 7 of 21

Device	Model / Reference	Registries	Class	Status
Rainbow	3777	FDA UDI	Class II	Active
MasimoSET® LNOP® Sensors application training packet	1282	FDA UDI	Class II	Active
MasimoSET® LNOPv™ Ad SpO2 Pulse Oximeter Adhesive Sensor Adult	1277	FDA UDI	Class II	Active
NomoLine™ Comfort HH Adult Nasal/Oral CO2 Cannula	4732	FDA UDI	Class II	Active
MasimoSET® rainbow® RC25-1RA rainbow® Patient Cable	3934	FDA UDI	Class II	Active
Pronto™ Spot Check Pulse CO-Oximeter	9232	FDA UDI	Class II	Active
Rd Set	4011	FDA UDI	Class II	Active
uSp02	9477	FDA UDI	Class II	Active
rainbow ReSposable Pulse CO-Oximeter Sensor System, pediatric/slender digit	3458	FDA UDI	Class II	Active
NomoLine-O LH Adult/Pediatric Airway Adapter Set	4454	FDA UDI	Class II	Active
Rad-67	9827	FDA UDI	Class II	Active
SatShare™ Interface NK01 Cable	1367	FDA UDI	Class II	Active
RD SET™ MD14-05 RD SET Series Patient Cable	4080	FDA UDI	Class II	Active
RD rainbow SET™ R25--1.5 RD rainbow SET Series Patient Cable	4074	FDA UDI	Class II	Active
Patient SafetyNet Console	25378	FDA UDI	Class II	Active
MasimoSET® PC04 LNOP® Series Patient Cable	1173	FDA UDI	Class II	Active
RD SET™ NK-05 RD SET Series Patient Cable	4191	FDA UDI	Class II	Active
Kit, Pronto Pulse CO-Oximeter DCI SC-200	3580	FDA UDI	Class II	Active
Kit, Pronto Pulse CO-Oximeter DCIP SC-200	3581	FDA UDI	Class II	Active
RD to M-LNC Adapter Cable RD SET™ or RD rainbow SET™ to M-LNC Adapter Cable	4090	FDA UDI	Class II	Active
EMMA™ Kit	3678	FDA UDI	N/A	Active
Root™	9515	FDA UDI	Class II	Active
RD SET™ MD20-12 RD SET Series Patient Cable	4104	FDA UDI	Class II	Active
Ras-45	4425	FDA UDI	Class II	Active
rainbow SET	4183	FDA UDI	Class II	Active
Rad-5® Handheld signal extraction pulse oximeter	9234	FDA UDI	Class II	Active
rainbow SET	4313	FDA UDI	Class II	Active
MasimoSET® LNC CMS LNCS® to Philips 12-pin Adapter Cable	2263	FDA UDI	Class II	Active
NomoLine™ HH Infant Airway Adapter Set	3829	FDA UDI	Class II	Active
Red LNC MD20-01 LNCS® Patient Cable	4251	FDA UDI	Class II	Active
RD to LNC Adapter Cable RD SET™ to LNC Adapter Cable, 3ft.	4089	FDA UDI	Class II	Active
ProCal+™ Masimo Cable ProCal 2M	1604	FDA UDI	Class II	Active
rainbow R1 25L SpHb SpO2 SpMet Adult/Neonatal Pulse CO-Oximeter Adhesive Sensor	2414	FDA UDI	Class II	Active
MasimoSET® VueLink® Cable	1841	FDA UDI	Class II	Active
MasimoSET® DC-12 SpO2 Adult Reusable Sensor	1969	FDA UDI	Class II	Active
MightySat	9942	FDA UDI	Class II	Active
Rad-8 Horizontal Signal Extraction Pulse Oximeter	9212	FDA UDI	Class II	Active
Masimo Forehead Sensor Headbands	3929	FDA UDI	Class II	Active
M-LNCS Neo-3 SpO2 Neonatal/Adult Pulse Oximeter Adhesive Sensor	2914-5	FDA UDI	Class II	Active
Radical-7®	9713	FDA UDI	Class II	Active
Rd Set	4475	FDA UDI	Class II	Active
SatShare™ Interface MS01 Cable	1789	FDA UDI	Class II	Active
14 pin to 20 pin Adapter Cable	2478	FDA UDI	Class II	Active
IRMA Airway Adapter	106260	FDA UDI	Class II	Active
NomoLine-O LH Pediatric Nasal/Oral CO2 Cannula with O2	4460	FDA UDI	Class II	Active
Rd Set	4012	FDA UDI	Class II	Active
MasimoSET® M-LNC-10 M-LNCS™ Series Patient Cable	2525	FDA UDI	Class II	Active
PXC2-16 Mountable Extension Cable	2371	FDA UDI	Class II	Active
Centroid	4302	FDA UDI	Class II	Active
LNCS-II rainbow	4059	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.