# K222389: ZEUS System

- Pathway: 510(k) (Traditional)
- Applicant: iRhythm Technologies, Inc.
- Decided: Feb 15, 2023 after 191 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). 56 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 58 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.

## Most influential descendants
- K252859: ZEUS Platform (FG0501US) (2026), 0 descendants of its own

## Indications for use
The device is intended to capture, analyze and report symptomatic and asymptomatic cardiac events and continuous electrocardiogram information for long-term monitoring. After wear, ECG data from compatible monitoring devices is processed and analyzed by the ZEUS System. A final report is generated on the beat-to-beat information from the entire ECG recording. For the Zio AT service, the ZEUS System supports the capture and analysis of automatically-detected arrhythmia events, as well as the analysis of uploaded patient-triggered events. The ZEUS System is indicated for use on patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety and patients who are asymptomatic. The reports are provided for review by the intended user to render a diagnosis based on clinical judgment and experience. It is not intended for use on critical care patients.

Source page: https://510kreport.com/device/K222389
Methodology: https://510kreport.com/methodology