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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 2 of 21

Device	Model / Reference	Registries	Class	Status
Rd Set E1	4015	FDA UDI	Class II	Active
Lncs	2690	FDA UDI	Class II	Active
Lncs-Ii	4069	FDA UDI	Class II	Active
NomoLine-O™ Sampling Line Training Kit	4669	FDA UDI	Class II	Active
SatShare™ Interface PM01 Cable	1840	FDA UDI	Class II	Active
MasimoSET® Red 25 LNC-4 LNCS® Patient Cable for SpO2	3630	FDA UDI	Class II	Active
Masimo Sensor	4935	FDA UDI	Class II	Active
RD Sedline	4329	FDA UDI	Class II	Active
MasimoSET® Red DCIP-dc12 SpO2 Pediatric Reusable Sensor	2257	FDA UDI	Class II	Active
Radius VSM	4889	FDA UDI	Class II	Active
MasimoSET® Red DBI-dc3 SpO2 Adult Reusable Sensor	2643	FDA UDI	Class II	Active
MasimoSET® rainbow® Extension Cable RC-EXT-8	3659	FDA UDI	Class II	Active
PXC2-30 Mountable Extension Cable	2373	FDA UDI	Class II	Active
SpO2.COM™ SpO2 disposable sensor sample pack	1851	FDA UDI	Class II	Active
Rad-8 Vertical Signal Extraction Pulse Oximeter	9193	FDA UDI	Class II	Active
Rd Set	4472	FDA UDI	Class II	Active
Lncs	2694	FDA UDI	Class II	Active
NomoLine™ HH Adult Nasal/Oral CO2 Cannula	3835	FDA UDI	Class II	Active
MasimoSET® M-LNCS™ NeoPt-3 SpO2 Neonatal Pulse Oximeter Adhesive Sensor	2517	FDA UDI	Class II	Active
RD SET Rad-G-1.5	4772	FDA UDI	Class II	Active
R2-20r Pediatric/Slender digit Pulse CO-Oximeter Reusable Optical Sensor (ROS)	3411	FDA UDI	Class II	Active
M-LNCS™ YI, Starter Kit	3958	FDA UDI	Class II	Active
Rd Set	4886	FDA UDI	Class II	Active
Rad-57™ Pulse CO-Oximeter™	9188	FDA UDI	Class II	Active
MasimoSET® ReSposable™ DB9 S-ROS 12U SpO2 Reusable Optical Sensor (ROS)	2621	FDA UDI	Class II	Active
MasimoSET® LNCS® Newborn SpO2 Infant/Pediatric Pulse Oximeter Adhesive Sensor	2413	EUDAMEDFDA UDI	Class II	Active
NomoLine-O™ LH Infant/Neonatal Airway Adapter Set	4640	FDA UDI	Class I	Active
NomoLine™ LH Pediatric Nasal CO2 Cannula with O2 4m	4625	FDA UDI	Class I	Active
RAM Dual Cable, Red25 LNC-10	3906	FDA UDI	Class II	Active
MasimoSET® Replacement Tapes	2308	FDA UDI	Class II	Active
Masimo	4610	FDA UDI	Class II	Active
MasimoSET® M-LNCS™ YI SpO2 Multisite Adult Reusable Sensor	2505	FDA UDI	Class II	Active
MasimoSET® PC-04-DB9 LNOP® to DB9 Connector Patient Cable	2288	FDA UDI	Class II	Active
LNCS-II rainbow	4067	FDA UDI	Class II	Active
NomoLine™ LH Adult Nasal/Oral CO2 Cannula with O2 4m	4628	FDA UDI	Class I	Active
IRMA™ Airway Adapter	106220	FDA UDI	Class II	Active
MasimoSET® LNCS® Inf-3 SpO2 Infant Pulse Oximeter Adhesive Sensor	2603	FDA UDI	Class II	Active
Stork	95093	FDA UDI	Class II	Active
NomoLine™ LH Pediatric Nasal/Oral CO2 Cannula	3823	FDA UDI	Class II	Active
RD rainbow SET™ MD20-12 RD rainbow SET Series Patient Cable	4073	FDA UDI	Class II	Active
MasimoSET® PC-12-DB9 LNOP® to DB9 Connector Patient Cable	2290	FDA UDI	Class II	Active
Nomoline	9921	FDA UDI	Class II	Active
MasimoSET Reprocessed LNCS® Adtx SpO2 Adult Pulse Oximeter Adhesive Sensor	2686	FDA UDI	Class II	Active
NomoLine-O™ LH Adult Nasal/Oral CO2 Cannula 4m	4636	FDA UDI	Class I	Active
MightySat, Bluetooth, PVI, RRp, Fingertip Pulse Oximeter	9900	FDA UDI	Class II	Active
Rd Set	4473	FDA UDI	Class II	Active
Patient Cable & Adult DBI Sensor	4868	FDA UDI	Class II	Active
MasimoSET® LNC™ MP10 Cable	2270	FDA UDI	Class II	Active
M-LNCS™ NeoPt-L Neonatal Pulse Oximeter Adhesive Sensor	3669	FDA UDI	Class II	Active
MasimoSET Red 25 LNC-10 LNCS® Patient Cable	3345	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

MDSS GmbH DE

Importers

Not available yet.

Notified Bodies

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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.