# K213357: Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Verily Life Sciences, LLC
- Decided: Jul 19, 2022 after 280 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K963725 (1997). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192415: Study Watch with Irregular Pulse Monitor, Verily Life Sciences, LLC (2020) Summary page 4.

## Indications for use
The Study Watch with Irregular Pulse Monitor is indicated for use by adult patients (22 years and older) who have been diagnosed with, or are susceptible to developing, atrial fibrillation enabling them to monitor and record their heart rhythms. Study Watch is also intended to record, store, transfer, and display single-channel electrocardiogram (ECQG) rhythms. The Study Watch is intended for prescription use only.

Source page: https://510kreport.com/device/K213357
Methodology: https://510kreport.com/methodology