FDA 510(k) · Withings
K252474: Withings BeamO (SCT02) (Withings)
Withings received FDA 510(k) K252474 for Withings BeamO (SCT02), with a decision date of Nov 10, 2025 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K252474 |
|---|---|
| Pathway | 510(k) |
| Applicant | Withings |
| Device name | Withings BeamO (SCT02) |
| Product code | DPS: Electrocardiograph |
| Regulation (21 CFR) | 870.2340 |
| Device class | Class 2 |
| Date received | Aug 6, 2025 |
| Decision date | Nov 10, 2025 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
Withings BeamO is intended to record, display (when prescribed or used under the care of a physician), I store, and transfer single-channel electrocardiogram (ECG) rhythms. It is indicated for use with individuals 22 years and older. Withings BeamO is a non-sterile, contactless, reusable clinical thermometer intended for the intermittent determination of human body temperature over the temporal artery as the measurement site on people of all ages. Withings BeamO is also an electronic stethoscope that enables the recording and transmission of auscultation sound data. Withings BeamO is intended to be used by professional users in a clinical environment or by lay users in a non-clinical environment on people of all ages. The electronic stethoscope is for medical diagnostics purposes only. The device is not intended for self-diagnosis.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code DPS is "Electrocardiograph", class 2, 21 CFR 870.2340.
Our labels for filtering: claim ECG, sensor ECG electrodes. These are heuristics, not FDA fields.