# K182456: Study Watch

- Pathway: 510(k) (Traditional)
- Applicant: Verily Life Sciences, LLC
- Decided: Jan 17, 2019 after 132 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: 7 generations back to K963725 (1997). 14 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171816: Kardia Band System, AliveCor, Inc. (2017) Summary page 4.

## Most influential descendants
- K192415: Study Watch with Irregular Pulse Monitor (2020), 2 descendants of its own
- 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 is intended to record, store, transfer, and display single-channel electrocardiogram (ECG) rhythms. The Study Watch is intended for use by healthcare professionals, adult patients (22 years or older) with known or suspected heart conditions, and health conscious individuals.

Source page: https://510kreport.com/device/K182456
Methodology: https://510kreport.com/methodology