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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 3 of 21

Device	Model / Reference	Registries	Class	Status
MasimoSET® LNOP® Neo-L SpO2 Neonatal/Adult Pulse Oximeter Adhesive Sensor	1798	FDA UDI	Class II	Active
M-LNCS™ to RD Adapter Cable M-LNCS to RD SET™ or RD rainbow SET™ Patient Cable	4093	FDA UDI	Class II	Active
Radius VSM	4825	FDA UDI	Class II	Active
Radius VSM	4826	FDA UDI	Class II	Active
MasimoSET® Standard Replacement Wraps	2260	FDA UDI	Class II	Active
Rad-87® Vertical signal extraction pulse co-oximeter®	9229	FDA UDI	Class II	Active
MasimoSET® LNOP® MP12 LNOP® to IVM/MMS®	2282	FDA UDI	Class II	Active
MasimoSET® Replacement Tapes for LNOP® Neo Sensors	1054	FDA UDI	Class II	Active
RD rainbow SET™ RA25-05 RD rainbow SET Series Patient Cable	4077	FDA UDI	Class II	Active
MasimoSET® MNC-I Adapter Cable 4ft.	2022	FDA UDI	Class II	Active
Irma™ Ax+	AX+ Bluepoint	FDA UDI	Class II	Active
RD SedLine	5109	FDA UDI	Class II	Active
LNOP® to RD Adapter Cable LNOP to RD SET™ or RD rainbow SET™ Patient Cable	4091	FDA UDI	Class II	Active
Nomoline	4412	FDA UDI	Class II	Active
NomoLine	4414	FDA UDI	Class II	Active
NomoLine-O™ LH Adult Nasal/Oral CO2 Cannula with O2 4m	4638	FDA UDI	Class I	Active
Rad-97	9785	FDA UDI	Class II	Active
rainbow	4482	FDA UDI	Class II	Active
ISA AX + Root	4376	FDA UDI	N/A	Active
O3™ Regional Oximeter	9637	FDA UDI	Class II	Active
NomoLine™ HH Pediatric Nasal/Oral CO2 Cannula with O2	3838	FDA UDI	Class II	Active
NomoLine-O™ LH Pediatric Nasal/Oral CO2 Cannula	4642	FDA UDI	Class I	Active
Rad-5v™ Handheld signal extraction pulse oximeter	9197	FDA UDI	Class II	Active
NomoLine-O™ LH Infant/Neonatal, Airway Adapter Set 4m	4631	FDA UDI	Class I	Active
Rad-87™ Vertical signal extraction pulse co-oximeter®	9144	FDA UDI	Class II	Active
Radical-7™ Handheld signal extraction pulse co-oximeter™	9183	FDA UDI	Class II	Active
rainbow	4480	FDA UDI	Class II	Active
RD rainbow SET™ MD20-1.5 RD rainbow SET Series Patient Cable	4071	FDA UDI	Class II	Active
Radius-7	4546	FDA UDI	Class II	Active
DCI-P-dc3 pediatric/slender digit SpO2, SpCO® & SpMet® reusable sensor	3658	FDA UDI	Class II	Active
MasimoSET® M-LNC-10-DB9 M-LNCS™ to DB9 Patient Cable	2535	FDA UDI	Class II	Active
Rad-57™ Pulse CO-Oximeter™	3676	FDA UDI	Class II	Active
SpO2.COM® NRC-180 Patient Cable	1810	FDA UDI	Class II	Active
rainbow R25-L SpCO SpO2 SpMet® Adult/Neonatal Pulse CO-Oximeter® Adhesive Sensor	2219	FDA UDI	Class II	Active
LiDCO	95099	FDA UDI	Class II	Active
M-LNCS™ Adtx-3 SpO2 Adult Pulse Oximeter Adhesive Sensor	2509	FDA UDI	Class II	Active
rainbow Replacement Tapes, R/R1 25L	2623	FDA UDI	Class II	Active
Red LNC MD20-10 LNCS® Patient Cable	4253	FDA UDI	Class II	Active
NomoLine™ HH Pediatric Nasal CO2 Cannula with O2	3834	FDA UDI	Class II	Active
MasimoSET rainbow DCI-6 adult SpO2, SpCO & SpMet reusable sensor	3657	FDA UDI	Class II	Active
NomoLine-O HH Adult Nasal/Oral CO2 Cannula with O2	4453	FDA UDI	Class II	Active
MasimoSET® LNOP® DCI® SpO2 Adult Reusable Finger Clip Sensor	1269	FDA UDI	Class II	Active
Radical-7™ Handheld signal extraction pulse co-oximeter®	9153	FDA UDI	Class II	Active
Isa Or+	9685	FDA UDI	Class II	Active
Masimo W1	95080-104	FDA UDI	Class II	Active
MasimoSET® LNOP® NeoPt SpO2 Neonatal Pulse Oximeter Adhesive Sensor	1003	FDA UDI	Class II	Active
Rad-67	9826	FDA UDI	Class II	Active
RD rainbow SET	4278	FDA UDI	Class II	Active
Nomoline ISA CO2	4198	FDA UDI	Class II	Active
Masimo	4468	FDA UDI	Class II	Active

Related Companies

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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.