# K201456: Scan Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Withings SA
- Decided: Oct 5, 2021 after 491 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K963725 (1997). 12 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140933: Alivecor Heart Monitor, AliveCor, Inc. (2014) Summary page 4.

## Most influential descendants
- K232512: Masimo W1 (2023), 2 descendants of its own
- K240229: Masimo W1 (2024), 1 descendant of its own
- K221260: CSF-3 (2023), 1 descendant of its own
- K243305: Masimo W1 (2025), 0 descendants of its own
- K232445: CSF-4 (CSF-4) (2024), 0 descendants of its own

## Recalls of this device
- Dec 19, 2022 · Class II · Z-1280-2023: A software bug eliminated the initial ECG activation and review of the ECG under a physician. However, the device is only cleared for use under the care of a physician.

## Indications for use
Scan Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The Scan Monitor also displays ECG rhythms and detects the presence of atrial fibrillation (when the monitor is prescribed or used under the care of a physician). The Scan Monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals. The Scan Monitor is also indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2). The Scan Monitor is intended for spot-checking of adult patients in hospitals, clinics, long-term care facilities, and homes.

Source page: https://510kreport.com/device/K201456
Methodology: https://510kreport.com/methodology