Is this your brand? Sign in to claim ownership.

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 16 of 21

Device	Model / Reference	Registries	Class	Status
MasimoSET® LNC-10-DB9 LNCS® to DB9 Patient Cable	2286	FDA UDI	Class II	Active
MasimoSET® M-LNC™ MP10 M-LNCS™ to IVM/MMS	2831	FDA UDI	Class II	Active
Satshare Cable, DS04	2979	FDA UDI	Class II	Active
Radius PCG™	EMMA Bluetooth kPa	FDA UDI	Class II	Active
DCIP SC 1000 1000 spot checks Pediatric/Slender digit Reusable Sensor	3648	FDA UDI	Class II	Active
MasimoSET® M-LNC-10-GE M-LNCS™ to GE Patient Cable	2533	FDA UDI	Class II	Active
Radius-PPG	4588	FDA UDI	Class II	Active
MasimoSET® Multisite-L Neo Wraps	2715	FDA UDI	Class II	Active
RD rainbow SET-2	4286	FDA UDI	Class II	Active
LNC MAC-SL2 LNCS® to Spacelabs adapter cable, 3m	3026	FDA UDI	Class II	Active
Rad-87® Vertical signal extraction pulse co-oximeter®	9228	FDA UDI	Class II	Active
Nomoline™ Airway Adapter Set	Airway Adapter Set	FDA UDI	Class II	Active
RD rainbow SET™ RA25-1.5 RD rainbow SET Series Patient Cable	4075	FDA UDI	Class II	Active
MasimoSET® Red PC-04 LNOP® SpO2 Patient Cable	2058	FDA UDI	Class II	Active
Rad-G	4325	FDA UDI	Class II	Active
Radical Docking Station RDS-1 signal extraction pulse oximeter	9021	FDA UDI	Class II	Active
NomoLine™ Adult Single Nasal Prong CO2 Cannula with Luer	3813	FDA UDI	Class II	Active
iSpO2 Pulse Oximeter Consumer (Large)	3587	FDA UDI	Class II	Active
RD SpO2	4870	FDA UDI	Class II	Active
M-LNCS™ ReSposable™ S-ROS 3U SpO2 Reusable Optical Sensor (ROS)	2472	FDA UDI	Class II	Active
RD SET™ MD14-08 RD SET Series Patient Cable	4108	FDA UDI	Class II	Active
Ram	4099	FDA UDI	Class II	Active
Satshare™ interface cable DO07	2969	FDA UDI	Class II	Active
MasimoSET® M-LNC™ SL-10 M-LNCS™ to Spacelabs Patient Cable	2714	FDA UDI	Class II	Active
Masimo SET	4318	FDA UDI	Class II	Active
uSpO2 Pulse Oximetry Cable for GE ApexPro® CH, CARESCAPE™ Telemetry T4 & T14	3449	FDA UDI	Class II	Active
MasimoSET MNC-I Adapter Cable, 10ft.	1819	FDA UDI	Class II	Active
NomoLine-O LH Adult Nasal/Oral CO2 Cannula	4458	FDA UDI	Class II	Active
rainbow DCI-dc8 SpCO SpMet SpO2 Adult Direct Connector Reusable Sensor	2407	FDA UDI	Class II	Active
Masimo	4229	FDA UDI	Class II	Active
SedLine Patient Cable	2480	FDA UDI	Class II	Active
LNCS-II rainbow	4068	FDA UDI	Class II	Active
NomoLine-O HH Adult Single Nasal Prong CO2 Cannula	4665	FDA UDI	Class I	Active
NomoLine™ HH Adult Nasal CO2 Cannula with O2	3833	FDA UDI	Class II	Active
LNCS SpO2	4873	FDA UDI	Class II	Active
Rad-8® Vertical signal extraction pulse oximeter	9191	FDA UDI	Class II	Active
Opioid Halo	4725	FDA UDI	Class II	Unknown
Kit, Pronto Pulse CO-Oximeter DCI SC-200, DCIP SC-200	3584	FDA UDI	Class II	Active
MasimoSET LNC-14 LNCS® Series Patient Cable	2013	FDA UDI	Class II	Active
RD SET™ MD20-1.5 RD SET Series Patient Cable	4102	FDA UDI	Class II	Active
RD SET™ GE-05 RD SET to GE Patient Cable	4084	FDA UDI	Class II	Active
Red LNC MD20-04 LNCS® Patient Cable	4252	FDA UDI	Class II	Active
NomoLine-O HH Pediatric Nasal CO2 Cannula	4644	FDA UDI	Class I	Active
Nomoline™ Adapter	Adapter	FDA UDI	Class II	Active
SatShare™ Interface DO01 Cable	1324	FDA UDI	Class II	Active
Patient Safety Net	25375	FDA UDI	Class II	Active
M-LNCS™ DCI-P SpO2 Pediatric/Slender digit Adult Reusable Finger Clip Sensor	2502	FDA UDI	Class II	Active
Radius-7	9903	FDA UDI	Class II	Active
LNOP® DC-195 SpO2 Adult Reusable Sensor	1560	FDA UDI	Class II	Active
MasimoSET® M-LNC™ MAC-180 M-LNCS™ to N-180 Patient Cable	2537	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.