Medical Device Manufacturer · US , Irvine , CA

Masimo Corporation - FDA 510(k) Cleared Devices

85 submissions · 83 cleared · Since 2004

Recent clearances: Radius VSM and Accessories, Masimo O3 Regional Oximeter, Radius VSM and Accessories

85
Total
83
Cleared
2
Denied

FDA 510(k) Regulatory Record - Masimo Corporation Cardiovascular

17 devices
1-17 of 17
Cleared Jun 04, 2026
Radius VSM and Accessories
K254209 · MHX
Cardiovascular · 157d
Cleared May 29, 2025
Radius VSM and Accessories
K250757 · MHX
Cardiovascular · 78d
Cleared Apr 03, 2025
Masimo W1
K243305 · DPS
Cardiovascular · 164d
Cleared Aug 08, 2024
Masimo W1
K240229 · DPS
Cardiovascular · 192d
Cleared May 03, 2024
Masimo Stork
K234021 · QYU
Cardiovascular · 135d
Cleared Nov 17, 2023
Masimo W1
K232512 · DPS
Cardiovascular · 91d
Cleared CT Jun 01, 2023
Radius VSM and Accessories
K223498 · MHX
Cardiovascular · 192d
Cleared Oct 08, 2021
Carescape SpO2 - Masimo
K212876 · DQA
Cardiovascular · 29d
Cleared Nov 17, 2017
Masimo Root Monitoring System and Accessories
K171121 · MWI
Cardiovascular · 214d
Cleared Sep 14, 2017
Masimo Rad-97 and Accessories
K170168 · MWI
Cardiovascular · 238d
Cleared May 26, 2017
Masimo O3 Regional Oximeter System
K162603 · MUD
Cardiovascular · 249d
Cleared Jun 21, 2016
Masimo Root Monitoring System and Accessories
K153225 · MWI
Cardiovascular · 228d
Cleared Jun 09, 2016
Masimo O3 Regional Oximeter System
K160526 · MUD
Cardiovascular · 105d
Cleared Feb 12, 2016
Masimo Root Vital Signs Monitoring System and Accessories
K151644 · MWI
Cardiovascular · 239d
Cleared Nov 25, 2014
Masimo Root Monitoring System and Accesories
K142394 · MWI
Cardiovascular · 90d
Cleared Jun 25, 2014
MASIMO ROOT MONITORING SYSTEM
K140188 · MWI
Cardiovascular · 152d
Cleared Jun 08, 2007
MASIMO PATIENT SAFETY NET
K071047 · MSX
Cardiovascular · 56d
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