Medical Device Manufacturer · US , Irvine , CA

Masimo Corporation

84 submissions · 82 cleared · Since 2004
84
Total
82
Cleared
2
Denied

Masimo Corporation — FDA 510(k) Submissions

Masimo Corporation has submitted 84 FDA 510(k) premarket notifications since 2004, of which 82 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Oximeter, Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms), Oximeter, Tissue Saturation, Electrocardiograph, Index-generating Electroencephalograph Software . Use the specialty filter in the sidebar to narrow results.

84 devices
1–25 of 84
Masimo O3 Regional Oximeter
K243324 · MUD Oximeter, Tissue Saturation · General & Plastic Surgery
Jul 2025 267d
Radius VSM and Accessories
K250757 · MHX Monitor, Physiological,... · Cardiovascular
May 2025 78d
Masimo W1
K243305 · DPS Electrocardiograph · Cardiovascular
Apr 2025 164d
Masimo W1
K240229 · DPS Electrocardiograph · Cardiovascular
Aug 2024 192d
Masimo Stork
K234021 · QYU Infant Pulse Rate And... · Cardiovascular
May 2024 135d
MightySat -OTC
K214115 · OLK Pulse Oximeter For... · Anesthesiology
Jan 2024 762d
Masimo Stork
K223721 · DQA Oximeter · Anesthesiology
Dec 2023 368d
Masimo W1
K232512 · DPS Electrocardiograph · Cardiovascular
Nov 2023 91d
ORi
DEN200076 · QWE Hyperoxia Monitoring... · Anesthesiology
Oct 2023 1025d
Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue
K232389 · DQA Oximeter · Anesthesiology
Sep 2023 29d
Radius VSM and Accessories
K223498 · MHX Monitor, Physiological,... · Cardiovascular
Jun 2023 192d
Masimo Rad-G with Temperature
K213676 · DQA Oximeter · Anesthesiology
Apr 2023 510d
Masimo SafetyNet
DEN200011 · QVT Monitor For Opioid... · Anesthesiology
Mar 2023 1136d
Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories
K212161 · MWI Monitor, Physiological,... · Anesthesiology
Mar 2023 602d
Masimo CARESCAPE SpO2 ? Masimo with SpHb
K221953 · DQA Oximeter · Anesthesiology
Aug 2022 30d
Masimo O3 Regional Oximeter System
K214072 · MUD Oximeter, Tissue Saturation · General & Plastic Surgery
May 2022 130d
Masimo SedLine Sedation Monitor and Accessories
K203113 · OLW Index-generating... · Anesthesiology
Feb 2022 498d
Carescape SpO2 - Masimo
K212876 · DQA Oximeter · Cardiovascular
Oct 2021 29d
Radius T wearable thermometer
K203215 · FLL Continuous Measurement... · General Hospital
Jun 2021 221d
EMMA Capnograph
K201590 · CCK Analyzer, Gas,... · Anesthesiology
Mar 2021 290d
Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor
K201770 · DQA Oximeter · Anesthesiology
Sep 2020 87d
Masimo O3 Regional Oximeter System
K201432 · MUD Oximeter, Tissue Saturation · General & Plastic Surgery
Aug 2020 89d
Masimo Rad-97 Pulse CO-Oximeter and Accessories
K193626 · MWI Monitor, Physiological,... · Anesthesiology
Aug 2020 228d
Masimo Centroid System
K191882 · MWI Monitor, Physiological,... · Anesthesiology
Apr 2020 282d
Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories
K193242 · MWI Monitor, Physiological,... · Anesthesiology
Feb 2020 94d

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