Cleared Traditional

Masimo W1

K243305 · Masimo Corporation · Cardiovascular
Apr 2025
Decision
164d
Days
Class 2
Risk

About This 510(k) Submission

K243305 is an FDA 510(k) clearance for the Masimo W1, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on April 3, 2025, 164 days after receiving the submission on October 21, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K243305 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 2024
Decision Date April 03, 2025
Days to Decision 164 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DPS — Electrocardiograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2340