Cleared Traditional

Withings BeamO (SCT02)

K252474 · Withings · Cardiovascular
Nov 2025
Decision
96d
Days
Class 2
Risk

About This 510(k) Submission

K252474 is an FDA 510(k) clearance for the Withings BeamO (SCT02), a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Withings (Issy-Les-Moulineaux, FR). The FDA issued a Cleared decision on November 10, 2025, 96 days after receiving the submission on August 6, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K252474 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 2025
Decision Date November 10, 2025
Days to Decision 96 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