MASIMO CORPORATION

FDA Device Registration & Listing · Irvine, CA, US · Registration 3009831876

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009831876
FEI Number
3009831876
Entity Name
MASIMO CORPORATION
City/State/Country
Irvine, CA, US
Establishment Address
9600 Jeronimo, Irvine, CA 92618, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
MASIMO CORPORATION (Owner Number: 9031881)
Owner / Operator Contact Address
52 Discovery, --, Irvine, CA 92618, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K082052
PMA Number
N/A

All Registered Proprietary Names

uSpO2 Cables NomoLine ISA CO2 NomoLine-O Accessories ISA CO2 Module NomoLine ISA OR+ NomoLine ISA AX+ NomoLine Accessories ISA AX+ Module Direct Connect Sensors SatShare Cables Masimo SET Radical Pulse Oximeter with SatShare Rad-G Sensor Rad-G YI Rad-G Patient SafetyNet RAS-125 RAS-125c RAS-45 Masimo SET Rad 57 cm Pulse CO-Oximeter Masimo SET Rad 57 m Pulse CO-Oximeter Masimo SET Red reusable sensors Pronto Red Reusable Sensors LNCS Reusable Sensors M-LNCS Reusable Sensors Rad-57 LNCS-II rainbow DCI 8 Lambda rainbow DCI rainbow DCI SC RAS-45 Neo LNCS YI M-LNCS YI IntelliVue Module Pronto

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQA Oximeter Cardiovascular Class 2 870.2700 2014-06-24
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2018-05-15
CAT Cannula, Nasal, Oxygen Anesthesiology Class 1 868.5340 2018-05-15
GWQ Full-Montage Standard Electroencephalograph Neurology Class 2 882.1400 2018-05-15
NHQ Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2018-05-15
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2018-05-15
NHP Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2018-05-15
CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2018-05-15
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2018-05-15
OLW Index-Generating Electroencephalograph Software Neurology Class 2 882.1400 2018-05-15
CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1700 2018-05-15
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2018-05-15
ORT Burst Suppression Detection Software For Electroencephalograph Neurology Class 2 882.1400 2018-05-15
DQA Oximeter Cardiovascular Class 2 870.2700 2018-05-15
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2018-05-15
DPZ Oximeter, Ear Cardiovascular Class 2 870.2710 2018-05-15
OLT Non-Normalizing Quantitative Electroencephalograph Software Neurology Class 2 882.1400 2018-05-15
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2018-05-15
CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1620 2018-05-15
NHO Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2018-05-15
OMC Reduced- Montage Standard Electroencephalograph Neurology Class 2 882.1400 2018-05-15
CCL Analyzer, Gas, Oxygen, Gaseous-Phase Anesthesiology Class 2 868.1720 2018-05-15
DQA Oximeter Cardiovascular Class 2 870.2700 2011-02-14
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2023-04-28
DQA Oximeter Cardiovascular Class 2 870.2700 2023-04-28
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2023-04-28
MSX System, Network And Communication, Physiological Monitors Cardiovascular Class 2 870.2300 2007-06-21
BZA Connector, Airway (Extension) Anesthesiology Class 1 868.5810 2013-08-26
DQA Oximeter Cardiovascular Class 2 870.2700 2013-08-26
DQA Oximeter Cardiovascular Class 2 870.2700 1999-12-30
DQA Oximeter Cardiovascular Class 2 870.2700 2011-02-14
DQA Oximeter Cardiovascular Class 2 870.2700 1999-12-30
JKS Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide Clinical Toxicology Class 1 862.3220 2011-02-14
DQA Oximeter Cardiovascular Class 2 870.2700 2011-02-14
DPZ Oximeter, Ear Cardiovascular Class 2 870.2710 2011-02-14
DQA Oximeter Cardiovascular Class 2 870.2700 2018-11-29
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2018-11-29
DQA Oximeter Cardiovascular Class 2 870.2700 2011-12-14
DPZ Oximeter, Ear Cardiovascular Class 2 870.2710 2006-07-18
DQA Oximeter Cardiovascular Class 2 870.2700 2006-07-18
DQA Oximeter Cardiovascular Class 2 870.2700 2011-02-14

Official Correspondent

Mathew Jimenez

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MASIMO CORPORATION
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3013250653 MASIMO CORPORATION Irvine, CA, US
3027256461 Masimo Medical Technologies (Malaysia) SDN BHD Pasir Gudang Johor, MY
3011353843 MASIMO CORPORATION Irvine, CA, US
3016674095 Industrial Vallera de Mexicali, S.A. de C.V. (Terra) Mexicali Baja California, MX
3004415095 Industrial Vallera de Mexicali, S. A. de C. V. Mexicali Mexico, MX

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K903523 Hewlett-Packard Co. HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE 1990-10-23
K973147 Nellcor Puritan Bennett, Inc. NPB-295 PULSE OXIMETER 1997-11-14
K231243 Guangdong Genial Technology Co., Ltd. Finger Clip Pulse Oximeter 2023-10-31
K971628 Somanetics Corp. SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) 1997-10-10
K153184 Shenzhen Caremed Medical Technology Co., Ltd. Caremed Reusable & Disposable SPO2 Sensors 2017-01-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0020-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M, Part Number CS08653
Z-0029-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M W/PRINTER, Part Number CS08659

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009831876. Last updated year: 2026. Please use registration number 3009831876 when referencing this establishment in official correspondence.
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