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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 8 of 21

Device	Model / Reference	Registries	Class	Status
SatShare	4508	FDA UDI	Class II	Active
Rad-97	9784	FDA UDI	Class II	Active
MasimoSET® Replacement Tapes for LNOPv Ne Sensors	1799	FDA UDI	Class II	Active
Rad-8® Horizontal signal extraction pulse oximeter	9192	FDA UDI	Class II	Active
Rad-67	9825	FDA UDI	Class II	Active
Rad-G	9849	FDA UDI	Class II	Active
Rd Set	4055	FDA UDI	Class II	Active
Kit, Pronto Pulse CO-Oximeter DCIP SC-400	3583	FDA UDI	Class II	Active
Rad-87™ Horizontal signal extraction pulse co-oximeter®	9345	FDA UDI	Class II	Active
Rainbow	3799	FDA UDI	Class II	Active
Rad-8 Horizontal Signal Extraction Pulse Oximeter	9285	FDA UDI	Class II	Active
MasimoSET® Accessory Ear Clip	1606	FDA UDI	Class II	Active
NomoLine™ Infant Nasal CO2 Cannula with Luer	3806	FDA UDI	Class II	Active
NomoLine-O HH Adult Nasal/Oral CO2 Cannula	4452	FDA UDI	Class II	Active
Rad-8® Vertical signal extraction pulse oximeter	9213	FDA UDI	Class II	Active
MasimoSET® M-LNCS™ NeoPt SpO2 Neonatal Pulse Oximeter Adhesive Sensor	2516	FDA UDI	Class II	Active
RD Rainbow SET™ M20-1.5 RD rainbow SET Series Patient Cable	4255	FDA UDI	Class II	Active
Rd	9992	FDA UDI	Class II	Active
MasimoSET® LNC-MAC-SL2 LNCS® to Spacelabs Adapter Cable	2336	FDA UDI	Class II	Active
SedLine® Patient Cable	3637	FDA UDI	Class II	Active
MasimoSET® M-LNC-4 M-LNCS™ Series Patient Cable	2524	FDA UDI	Class II	Active
MasimoSET® uSpO2™ Pulse Oximetry Cable for GE ApexPro® FH	3450	FDA UDI	Class II	Active
MightySat, Bluetooth, PVI, Fingertip Pulse Oximeter, RX Only	9909	FDA UDI	Class II	Active
Rd Set	4002	FDA UDI	Class II	Active
MasimoSET® M-LNC™ MAC CMS M-LNCS™ to Philips 12-pin Adapter Cable	2539	FDA UDI	Class II	Active
MasimoSET® Red 25 PC-4 LNOP® Patient Cable for SpO2	3629	FDA UDI	Class II	Active
MasimoSET® LNOP® Adt SpO2 Adult Pulse Oximeter Adhesive Sensor	1001	FDA UDI	Class II	Active
MasimoSET Red LNC-04 LNCS® Patient Cable	2055	FDA UDI	Class II	Active
SpO2.COM® NRC-P12 Patient Cable	1853	FDA UDI	Class II	Active
Rad-5® Handheld signal extraction pulse oximeter	9196	FDA UDI	Class II	Active
NomoLine™ HH Infant/Neonatal Airway Adapter Set	4367	FDA UDI	Class II	Active
MasimoSET LNCS® DCI® SpO2 Adult Reusable Finger Clip Sensor	1863	FDA UDI	Class II	Active
SatShare™ Interface HP03 Cable	1357	FDA UDI	Class II	Active
Masimo W1	95137	FDA UDI	Class II	Active
Rd Set	4470	FDA UDI	Class II	Active
Rad-8 Horizontal Signal Extraction Pulse Oximeter	9218	FDA UDI	Class II	Active
LNCS-II rainbow	4062	FDA UDI	Class II	Active
Irma	4495	FDA UDI	Class II	Active
MasimoSET® LNCS® to PC Adapter Cable	1816	FDA UDI	Class II	Active
uSp02	9476	FDA UDI	Class II	Active
MasimoSET® LNCS® NeoPt Neonatal Pulse Oximeter Adhesive Sensor	2321	EUDAMEDFDA UDI	Class II	Active
RD SET Rad-G-5	4773	FDA UDI	Class II	Active
Rad-57™ Pulse CO-Oximeter™	9217	FDA UDI	Class II	Active
Masimo	4612	FDA UDI	Class II	Active
SatShare	9756	FDA UDI	Class II	Active
Rad-57c	9179	FDA UDI	Class II	Active
NomoLine-O HH Pediatric Nasal/Oral CO2 Cannula	4646	FDA UDI	Class I	Active
MasimoSET® Red 25 LNC-1RA LNCS® Patient Cable for SpO2	3936	FDA UDI	Class II	Active
NomoLine ISA™ AX+	9923	FDA UDI	Class II	Active
MasimoSET® Masimo Headband	1608	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.