# K213409: ZEUS System (Zio Watch)

- Pathway: 510(k) (Traditional)
- Applicant: iRhythm Technologies, Inc.
- Decided: Jul 19, 2022 after 273 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K882803 (1988). 70 ancestors in all.
No later device cites it as a predicate yet.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202527: Zio ECG Utilization Software (ZEUS) System, iRhythm Technologies, Inc. (2021) Summary page 4.
- K192415: Study Watch with Irregular Pulse Monitor, Verily Life Sciences, LLC (2020) Summary page 4.

## Indications for use
The ZEUS System (Zio Watch), as part of the Zio Watch Service, is intended to process and analyze electrocardiogram (ECG) and photoplethysmogram (PPG) based data to detect and report on the presence of Atrial Fibrillation (AF) over the monitoring period. The report provides ECG information for the intended user to diagnose AF and contextual information for AF, both to be interpreted based on clinical judgment and experience. It is indicated for use on adult patients 22 years or older who are susceptible to developing or who have been diagnosed with AF. It is not intended for use on critical care patients.

Source page: https://510kreport.com/device/K213409
Methodology: https://510kreport.com/methodology