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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 15 of 21

Device	Model / Reference	Registries	Class	Status
RainbowSET RAM Dual Cable, RC-10	3660	FDA UDI	Class II	Active
MasimoSET® rainbow Acoustic Respiration Sensor Sample Pack adult RRa sensors	3456	FDA UDI	Class II	Active
Rad-97	9868	FDA UDI	Class II	Active
rainbow SET	4331	FDA UDI	Class II	Active
SedLine	4432	FDA UDI	Class II	Active
Rad-87™ Horizontal signal extraction pulse co-oximeter®	9283	FDA UDI	Class II	Active
NomoLine™ LH Adult Nasal CO2 Cannula with O2 4m	4624	FDA UDI	Class I	Active
MasimoSET DBI-dc8 SpO2 Adult Reusable Sensor	2652	FDA UDI	Class II	Active
rainbow® DC-3 SC 200 SpHb® SpO2 SpMet® 200 spot checks Adult Reusable Sensor	2646	FDA UDI	Class II	Active
rainbow SET	4513	FDA UDI	Class II	Active
MasimoSET® M-LNCS® Patient Cable Red M- LNCv-10	3514	FDA UDI	Class II	Active
MasimoSET® Replacement Tapes	1801	FDA UDI	Class II	Active
rainbow	4485	FDA UDI	Class II	Active
SatShare™ Interface SL01 Cable	1323	FDA UDI	Class II	Active
NomoLine™ HH Adult Single Nasal Prong CO2 Cannula	3839	FDA UDI	Class II	Active
SatShare Cable DO05	2023	FDA UDI	Class II	Active
Rd Set	4012	FDA UDI	Class II	Active
NomoLine™ HH Pediatric Nasal CO2 Cannula	3831	FDA UDI	Class II	Active
LNC-10 to NK LNCS® to NK Patient Cable	3984	FDA UDI	Class II	Active
Radius VSM	4888	FDA UDI	Class II	Active
NomoLine	4991	FDA UDI	Class I	Active
rainbow® M20-12, rainbow® Patient Cable	4238	FDA UDI	Class II	Active
NomoLine™ LH Adult Nasal CO2 Cannula	3817	FDA UDI	Class II	Active
RAS Rra	4287	FDA UDI	Class II	Active
Sedline® Seditation Monitor	9513	FDA UDI	Class II	Active
LNCS SpO2	4876	FDA UDI	Class II	Active
Irma™ Co2	4428	FDA UDI	Class II	Active
Radius-PPG	4582	FDA UDI	Class II	Active
LNCS-II rainbow	4063	FDA UDI	Class II	Active
Nomoline™	108210	FDA UDI	Class II	Unknown
rainbow	3798	FDA UDI	Class II	Active
NomoLine-O LH Adult Nasal CO2 Cannula with O2	4456	EUDAMEDFDA UDI	Class II	Active
Masimo SET	4730	FDA UDI	Class II	Active
RD SET™ MP-05 RD SET to IVM/MMS	4082	FDA UDI	Class II	Active
Rd Set Tfa-1	4016	FDA UDI	Class II	Active
MasimoSET® uSpO2™ Pulse Oximetry Cable for GE ApexPro® FH	3578	FDA UDI	Class II	Active
Masimo SET	4322	FDA UDI	Class II	Active
RD Sedline	4298	FDA UDI	Class II	Active
MasimoSET Red MNC Adapter Cable	2642	FDA UDI	Class II	Active
MightySat™ Fingertip Pulse Oximeter	9700	FDA UDI	Class II	Active
MasimoSET® SofTouch™ Replacement Wraps	2309	FDA UDI	Class II	Active
SatShare™ Interface DS03 Cable	1365	FDA UDI	Class II	Active
MasimoSET® PC-12-GE LNOP® to GE Patient Cable	1890	FDA UDI	Class II	Active
RD SET™ Neo SpO2, PR, PI, PVI® Neonatal/Adult Pulse Oximeter Adhesive Sensor	4003	FDA UDI	Class II	Active
LNCS® Sensor Sample Pack	2346	FDA UDI	Class II	Active
RD SET™ NK-12 RD SET Series Patient Cable	4192	FDA UDI	Class II	Active
Masimo	4611	FDA UDI	Class II	Active
Replacement Tapes for RD SET Neo	4047	FDA UDI	Class II	Active
Rd Set	4013	FDA UDI	Class II	Active
RD Rainbow SET™ M20-05 RD rainbow SET Series Patient Cable	4256	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

MDSS GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.