K252474 is an FDA 510(k) clearance for the Withings BeamO (SCT02). Classified as Electrocardiograph (product code DPS), Class II - Special Controls.
Submitted by Withings (Issy-Les-Moulineaux, FR). The FDA issued a Cleared decision on November 10, 2025 after a review of 96 days - within the typical 510(k) review window.
This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.
View all Withings devices
NCT06351761
Completed
Interventional
Industry-sponsored
WIBOFA - Validation of SCT02 With ECG-App for Detection of AF
Validation of Withings BeamO With Withings ECG-App for the Detection of Atrial Fibrillation
| Condition studied |
Atrial Fibrillation |
| Study design |
Parallel |
| Eligibility |
All sexes
· 22 Years+
· Healthy volunteers accepted
|
| Sponsor |
Withings
(industry)
|
Started 2024-06-03
→
Primary completion 2025-06-10
→
Completed 2025-11-26
Primary outcome
Co-primary outcome 1 - Sensitivity of Investigational Device
Secondary outcome
Rhythm classification by ranges of heart rate
Study completed - no results published.
This trial concluded in 2025 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
Individual participant data will not be shared.
View full study on ClinicalTrials.gov