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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 5 of 21

Device	Model / Reference	Registries	Class	Status
Rainbow 4D DC Pronto 7, Direct Connect, Spot Check, Reusable Sensor	9147	FDA UDI	Class II	Active
Data Transfer™ Download Cable, Red 20-pin	2063	FDA UDI	Class II	Active
Radical-7™ Handheld signal extraction pulse co-oximeter™	9177	FDA UDI	Class II	Active
MasimoSET® Cleanshield™ Multisite Wrap	1596	FDA UDI	Class II	Active
NomoLine™ Pediatric Nasal CO2 Cannula with O2 and Luer	3808	FDA UDI	Class II	Active
Rd Set	4014	FDA UDI	Class II	Active
MasimoSET® LNOPv™ Pd SpO2 Pulse Oximeter Adhesive Sensor Pediatric	3925	FDA UDI	Class II	Active
MasimoSET® rainbow RC-12 rainbow® Patient Cable	2404	FDA UDI	Class II	Active
MasimoSET® M-LNCS™ NeoPt-500 SpO2 Neonatal Pulse Oximeter Adhesive Sensor	2518	FDA UDI	Class II	Active
MasimoSET®Red 25 LNC-1 LNCS® Patient Cable for SpO2	3935	FDA UDI	Class II	Active
M-LNCS™ Neo Sample Pack	2658	FDA UDI	Class II	Active
Replacement Tapes for RD SET Inf	4046	FDA UDI	Class II	Active
RD rainbow SET™ MD20-05 RD rainbow SET Series Patient Cable	4072	FDA UDI	Class II	Active
NomoLine-O HH Infant Nasal CO2 Cannula	4664	FDA UDI	Class I	Active
Radius-7	9917	FDA UDI	Class II	Active
Isa™ Or+	OR+ ROOT	FDA UDI	Class II	Active
MasimoSET® M-LNCS™ TF-I SpO2 Adult Reusable Forehead Sensor	2504	FDA UDI	Class II	Active
MasimoSET® LNOP® YI SpO2 Multisite Reusable Sensor	1544	FDA UDI	Class II	Active
MasimoSET® M-LNCS® Patient Cable M-LNCv-10	3510	FDA UDI	Class II	Active
RD rainbow SET-2	4027	FDA UDI	Class II	Active
RD SpO2	4872	FDA UDI	Class II	Active
Masimo	4613	FDA UDI	Class II	Active
Rd Set	4054	FDA UDI	Class II	Active
EMMA™ Capnometer	mmHg	FDA UDI	Class II	Unknown
MasimoSET® LNOPv™Ne SpO2 Pulse Oximeter Adhesive Sensor Adult/Neonatal	1831	FDA UDI	Class II	Active
M-LNCS™ Adult Sample Pack	2657	FDA UDI	Class II	Active
M-LNCS DCI SpO2 Adult Reusable Finger Clip Sensor	2501	FDA UDI	Class II	Active
Light Shield	2357	FDA UDI	Class II	Active
NomoLine™ Adult/Pediatric Airway Adapter Set 3m with Luer	3802	FDA UDI	Class II	Active
IRMA™ CO2 Root	CO2 Root	FDA UDI	Class II	Active
Radius PPG	9954	FDA UDI	Class II	Active
MasimoSET® LNOP® Multisite-L reusable sensor	2191	FDA UDI	Class II	Active
M-LNCS™ Adtx SpO2 Adult Pulse Oximeter Adhesive Sensor	2508	FDA UDI	Class II	Active
NomoLine™ Adult Nasal/Oral CO2 Cannula with O2 and Luer	3811	FDA UDI	Class II	Active
RD SET™ MP-12 RD SET to IVM/MMS	4083	FDA UDI	Class II	Active
Rad-97	9796	FDA UDI	Class II	Active
NomoLine	4417	FDA UDI	Class II	Active
MasimoSET® LNC-14-DB9 LNCS® to DB9 Patient Cable	2287	FDA UDI	Class II	Active
DCIP-dc12 SpCO SpMet SpO2 Pediatric/Slender digit Direct Connect Reusable Sensor	2070	FDA UDI	Class II	Active
Root	9905	FDA UDI	Class II	Active
RD rainbow	4690	FDA UDI	Class II	Active
Isa™ Co2	CO2	FDA UDI	Class II	Active
Radius VSM	4827	FDA UDI	Class II	Active
Rad-57™ Pulse CO-Oximeter™	3734	FDA UDI	Class II	Active
M-LNCS™ Sensor Sample Pack, 3ft.	2656	FDA UDI	Class II	Active
NomoLine™ LH Infant/Neonatal, Airway Adapter Set 4m	4621	FDA UDI	Class I	Active
MasimoSET® M-LNCS™ DBI SpO2 Adult Soft Reusable Sensor	2507	FDA UDI	Class II	Active
MasimoSET® rainbow RAS-125c adult/pediatric acoustic respiration cloth sensor	3475	FDA UDI	Class II	Active
MasimoSET® LNC SL-10 LNC to Spacelabs Patient Cable	2432	FDA UDI	Class II	Active
NomoLine-O™ LH Pediatric Nasal/Oral CO2 Cannula 4m	4637	FDA UDI	Class I	Active

Related Companies

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MDSS GmbH DE

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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.