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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 11 of 21

Device	Model / Reference	Registries	Class	Status
NomoLine™ LH Pediatric Nasal CO2 Cannula 4m	4623	FDA UDI	Class I	Active
MasimoSET® LNCS® Trauma SpO2 Adult Pulse Oximeter Adhesive Sensor	2411	EUDAMEDFDA UDI	Class II	Active
MasimoSET® LNCS® DBI SpO2 Adult Soft Reusable Sensor	2653	EUDAMEDFDA UDI	Class II	Active
iSpO2, Small, Consumer, Lightning	9574	FDA UDI	Class II	Active
NomoLine	4419	FDA UDI	Class II	Active
Rad-5® Handheld signal extraction pulse oximeter	9214	FDA UDI	Class II	Active
rainbow® M20-01 rainbow® Patient Cable	4236	FDA UDI	Class II	Active
Isa™ Co2	CO2 LEMO	FDA UDI	Class II	Active
NomoLine™ LH Adult Single Nasal Prong CO2 Cannula	3826	FDA UDI	Class II	Active
EMMA™ Airway Adapter	17449	FDA UDI	Class I	Active
MEDIUM Radius-7™ Arm Band	37098	FDA UDI	Class II	Active
MasimoSET® LNOP® DCI-P® SpO2 Pediatric/Slender digit Reusable Finger Clip Sensor	1276	FDA UDI	Class II	Active
Masimo W1	95080-106	FDA UDI	Class II	Active
EMMA™ Kit	3639	FDA UDI	Class II	Active
ReSposable S-DOS 30L SpO2 Adult/Infant Pulse Oximeter Disposable Optical Sensor	2471	FDA UDI	Class II	Active
SedLine	4497	FDA UDI	Class II	Active
Irma™ Ax+	4767	FDA UDI	Class II	Active
LNCS™ ReSposable™ S-ROS 3U SpO2 Reusable Optical Sensor (ROS)	2473	FDA UDI	Class II	Active
MasimoSET® rainbow RC-4 rainbow® Patient Cable	2406	FDA UDI	Class II	Active
RD SET™ SL-12 RD SET to SpaceLabs Patient Cable	4087	FDA UDI	Class II	Active
MasimoSET® LNC-MAC-395 LNCS® Series to N-395 Adapter Cable	2269	FDA UDI	Class II	Active
rainbow ReSposable R2-20a Pediatric/Slender Digit Pulse CO-Oximeter Sensor	2755	FDA UDI	Class II	Active
RD Rainbow SET™ MD20-08 Rd rainbow SET Series Patient Cable	4109	FDA UDI	Class II	Active
MasimoSET® LNCS® Patient Cable LNCv-4	3507	FDA UDI	Class II	Active
RD Rainbow SET™ M20-12 RD rainbow SET Series Patient Cable	4257	FDA UDI	Class II	Active
PXC2-UT16 Mountable Extension Cable	2372	FDA UDI	Class II	Active
Rad-57™ Pulse CO-Oximeter™	3736	FDA UDI	Class II	Active
Rd Set	4615	FDA UDI	Class II	Active
ISA™ Gas Exhaust Kit	4409	FDA UDI	Class I	Active
NomoLine™ LH Infant Nasal CO2 Cannula	3819	FDA UDI	Class II	Active
SpO2.COM® NRC-GE Patient Cable	1854	FDA UDI	Class II	Active
NomoLine	4933	FDA UDI	Class II	Active
RD rainbow SET-2	4026	FDA UDI	Class II	Active
Rad-8 Horizontal Signal Extraction Pulse Oximeter	9282	FDA UDI	Class II	Active
Rad-87™ Horizontal signal extraction pulse co-oximeter®	9226	FDA UDI	Class II	Active
Masimo SET	4775	FDA UDI	Class II	Active
RD SET™ DCI-P SpO2 Pediatric/Slender digit Reusable Finger Clip Sensor	4051	FDA UDI	Class II	Active
rainbow® DCI® SC 400 SpHb® SpO2 SpMet® 400 spot checks Adult Reusable Sensor	3420	FDA UDI	Class II	Active
O3	4235	FDA UDI	Class II	Active
Pronto	9757	FDA UDI	Class II	Active
Root™ with noninvasive blood pressure and temperature	9695	FDA UDI	Class II	Active
Rad-97	9867	FDA UDI	Class II	Active
Kit, Pronto Pulse CO-Oximeter DCI SC-400	3582	FDA UDI	Class II	Active
M-LNCS™ Neo-L Neonatal/Adult Pulse Oximeter Adhesive Sensor	3668	FDA UDI	Class II	Active
Small Radius-7™ Arm Band	37097	FDA UDI	Class II	Active
Radius PPG	4583	FDA UDI	Class II	Active
MasimoSET® M-LNC™ MP4 M-LNCS™ to IVM/MMS	3754	FDA UDI	Class II	Active
MasimoSET® LNOP® Blue® SpO2 Cyanotic Pulse Oximeter Adhesive Sensor	1970	FDA UDI	Class II	Active
MasimoSET® Red 25 PC-4RA LNOP® Patient Cable for SpO2	3631	FDA UDI	Class II	Active
Radius PPG	5276	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.