# K192415: Study Watch with Irregular Pulse Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Verily Life Sciences, LLC
- Decided: Jan 17, 2020 after 135 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: 8 generations back to K963725 (1997). 17 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182456: Study Watch, Verily Life Sciences, LLC (2019) Summary page 4.
- K173872: FibriCheck, Qompium NV (2018) Summary page 4.

## Most influential descendants
- K213357: Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor (2022), 0 descendants of its own
- K213409: ZEUS System (Zio Watch) (2022), 0 descendants of its own

## 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 (ECG) rhythms. The Irregular Pulse Monitor is indicated for use in professional healthcare facility environments, while worn as a wrist watch.

Source page: https://510kreport.com/device/K192415
Methodology: https://510kreport.com/methodology