Masimo Corporation

FDA Device Registration & Listing · Irvine, CA, US · Registration 3019388613

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
3019388613
FEI Number
3019388613
Entity Name
Masimo Corporation
City/State/Country
Irvine, CA, US
Establishment Address
15750 Alton Parkway, Irvine, CA 92618, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
MASIMO CORPORATION (Owner Number: 9031881)
Owner / Operator Contact Address
52 Discovery, --, Irvine, CA 92618, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K090165
PMA Number
N/A

All Registered Proprietary Names

MightySat Rx uSpO2 Cables Red MNC Cable NC Adapter Cable MNC Cable IRMA Airway Adapter IRMA AX+ IRMA CO2 rainbow SpHb Disposable Sensors LNCS Sterile Sensors Pronto RD rainbow Lite SET-1 RD rainbow 4 Lambda RD rainbow SET-2 Radius VSM and Accessories Radius VSM RAS-45 RD SET CS Disposable Sensors LNCS Disposable Sensors M-LNCS Disposable Sensors Direct Connect Sensors SatShare Cables Masimo SET Radical Pulse Oximeter with SatShare Masimo SafetyNet RD SET Neo iSpO2 MightySat Pronto Rad-G Sensor Rad-G YI Rad-G SedLine Sensors SedLine Module RD SedLine Sensors Rad-97 Radical Docking Station Radical-7 Stork Hub Stork Vitals Stork Vitals+ Stork Sensor Red Reusable Sensors LNCS Reusable Sensors M-LNCS Reusable Sensors Stork Hub Stork Vitals Stork Sensor Stork Vitals+ NomoLine ISA CO2 NomoLine-O Accessories ISA CO2 Module NomoLine ISA OR+ NomoLine ISA AX+ NomoLine Accessories ISA AX+ Module Root Centroid Masimo W1 IntelliVue Module Rad-57 LNCS-II rainbow DCI 8 Lambda rainbow DCI rainbow DCI SC MAC Adapter Cable AC-1 Adapter Cable Rad-5v Rad-5 Radius-7 RAS-45 Neo CareScape SpO2 - Masimo rainbow SET IntelliVue Module RAS-125 RAS-125c RAS-45 rainbow DCI-mini Rad-67 Rainbow ReSposable Sensors Rainbow ReSposable U Sensors

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQA Oximeter Cardiovascular Class 2 870.2700 2019-02-12
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2019-02-12
DQA Oximeter Cardiovascular Class 2 870.2700 2014-06-24
DQA Oximeter Cardiovascular Class 2 870.2700 2011-02-14
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2022-03-28
CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2022-03-28
NHO Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2022-03-28
NHQ Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2022-03-28
CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1620 2022-03-28
NHP Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2022-03-28
CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1700 2022-03-28
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 2011-02-14
DQA Oximeter Cardiovascular Class 2 870.2700 2011-02-14
QWE Hyperoxia Monitoring Device Adjunct To Pulse Oximetry Anesthesiology Class 2 870.2720 2024-06-25
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2023-06-05
DPZ Oximeter, Ear Cardiovascular Class 2 870.2710 2023-06-05
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2023-06-05
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2023-06-05
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2023-06-05
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2023-06-05
DSJ Alarm, Blood-Pressure Cardiovascular Class 2 870.1100 2023-06-05
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2023-06-05
KMI Monitor, Bed Patient General Hospital Class 1 880.2400 2023-06-05
DQA Oximeter Cardiovascular Class 2 870.2700 2023-06-05
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2023-06-05
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2023-06-05
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2023-06-05
DQA Oximeter Cardiovascular Class 2 870.2700 2011-02-14
DQA Oximeter Cardiovascular Class 2 870.2700 2011-02-14
OUG Medical Device Data System General Hospital Class 1 880.6310 2013-07-12
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2021-05-14
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2021-05-14
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2021-05-14
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2021-05-14
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2021-05-14
JKS Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide Clinical Toxicology Class 1 862.3220 2021-05-14
DQA Oximeter Cardiovascular Class 2 870.2700 2021-05-14
OCH Oximeter, Infrared, Sporting, Aviation Cardiovascular Class 2 870.2700 2016-01-27
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
ORT Burst Suppression Detection Software For Electroencephalograph Neurology Class 2 882.1400 2022-03-22
OMC Reduced- Montage Standard Electroencephalograph Neurology Class 2 882.1400 2022-03-22
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2022-03-22
OLW Index-Generating Electroencephalograph Software Neurology Class 2 882.1400 2022-03-22
OLT Non-Normalizing Quantitative Electroencephalograph Software Neurology Class 2 882.1400 2022-03-22
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2024-06-25
JKS Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide Clinical Toxicology Class 1 862.3220 2024-06-25
DQA Oximeter Cardiovascular Class 2 870.2700 2024-06-25
DPZ Oximeter, Ear Cardiovascular Class 2 870.2710 2024-06-25
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2024-06-25
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2024-06-25
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2024-06-25
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2024-06-25
QYU Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use Cardiovascular Class 2 870.2705 2024-08-14
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2024-08-14
DQA Oximeter Cardiovascular Class 2 870.2700 1999-12-30
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2024-01-23
DQA Oximeter Cardiovascular Class 2 870.2700 2024-01-23
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
KMI Monitor, Bed Patient General Hospital Class 1 880.2400 2020-08-03
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2020-08-03
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2020-08-03
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2024-10-17
DQA Oximeter Cardiovascular Class 2 870.2700 2024-10-17
DXH Transmitters And Receivers, Electrocardiograph, Telephone Cardiovascular Class 2 870.2920 2024-10-17
DPZ Oximeter, Ear Cardiovascular Class 2 870.2710 2006-07-18
DQA Oximeter Cardiovascular Class 2 870.2700 2006-07-18
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 1999-12-30
DQA Oximeter Cardiovascular Class 2 870.2700 2011-02-14
DPZ Oximeter, Ear Cardiovascular Class 2 870.2710 2011-02-14
JKS Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide Clinical Toxicology Class 1 862.3220 2021-03-09
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2021-03-09
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2021-03-09
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2021-03-09
DPZ Oximeter, Ear Cardiovascular Class 2 870.2710 2021-03-09
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2021-03-09
DQA Oximeter Cardiovascular Class 2 870.2700 2021-03-09
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2021-03-09
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 2024-10-17
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 2019-08-07
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2010-12-06
JKS Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide Clinical Toxicology Class 1 862.3220 2010-12-06
DQA Oximeter Cardiovascular Class 2 870.2700 2010-12-06

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
3009831876 MASIMO CORPORATION Irvine, CA, US
3011353843 MASIMO CORPORATION Irvine, CA, US
3016674095 Industrial Vallera de Mexicali, S.A. de C.V. (Terra) Mexicali Baja California, MX

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K201432 Masimo Corporation Masimo O3 Regional Oximeter System 2020-08-29
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

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 3019388613. Last updated year: 2026. Please use registration number 3019388613 when referencing this establishment in official correspondence.
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