# K252474: Withings BeamO (SCT02)

- Pathway: 510(k) (Traditional)
- Applicant: Withings
- Decided: Nov 10, 2025 after 96 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K952882 (1996). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130921: Alivecor Heart Monitor Otc, AliveCor, Inc. (2014) Summary page 5.
- K160544: Withings Thermo (Model SCT01), Withings (2016) Summary page 5.
- K181612: Tyto Stethoscope (OTC), Tyto Care, Ltd. (2018) Summary page 6.

## Indications for use
Withings BeamO is intended to record, display (when prescribed or used under the care of a physician), 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.

Source page: https://510kreport.com/device/K252474
Methodology: https://510kreport.com/methodology