# K230812: Withings Scan Monitor 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Withings
- Decided: Aug 23, 2023 after 152 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: 6 generations back to K963725 (1997). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201456: Scan Monitor, Withings SA (2021) Summary page 4.

## Indications for use
The Withings Scan Monitor 2.0 is intended to record, store and transfer lead II and lead-III of a two-channel electrocardiogram (ECG). In addition, it calculates and displays leads I, aVR, aVF, aVL. The Withings Scan Monitor 2.0 also displays ECG rhythms and detects the presence of atrial fibrillation (when the monitor is prescribed or used under care of a physician). The Withings Scan Monitor 2.0 is intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals. The Withings Scan Monitor 2.0 is intended for adult patients in hospitals, clinics, long-term care facilities, and homes.

Source page: https://510kreport.com/device/K230812
Methodology: https://510kreport.com/methodology