Cleared Traditional

Radius VSM and Accessories

K250757 · Masimo Corporation · Cardiovascular
May 2025
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K250757 is an FDA 510(k) clearance for the Radius VSM and Accessories, a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on May 29, 2025, 78 days after receiving the submission on March 12, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K250757 FDA.gov
FDA Decision Cleared SESE
Date Received March 12, 2025
Decision Date May 29, 2025
Days to Decision 78 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MHX — Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1025

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