Cleared Traditional

Radius VSM and Accessories

K223498 · Masimo Corporation · Cardiovascular
Jun 2023
Decision
192d
Days
Class 2
Risk

About This 510(k) Submission

K223498 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 June 1, 2023, 192 days after receiving the submission on November 21, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K223498 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 2022
Decision Date June 01, 2023
Days to Decision 192 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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