Masimo Corporation - FDA 510(k) Cleared Devices

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