# K252859: ZEUS Platform (FG0501US)

- Pathway: 510(k) (Traditional)
- Applicant: iRhythm Technologies, Inc.
- Decided: May 29, 2026 after 262 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: 16 generations back to K882803 (1988). 57 ancestors in all.
No later device cites it as a predicate yet.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222389: ZEUS System, iRhythm Technologies, Inc. (2023) Summary page 5.

## Indications for use
The Zio ECG Utilization Software (ZEUS) Platform is intended to process, store, and analyze electrocardiogram (ECG) recordings captured from a compatible ECG monitor, including automatically detected arrhythmia events and patient-triggered events. The ZEUS Platform also allows for review of the analyzed data and, subsequently, report generation. Interpretation of the analyzed ECG data and the associated diagnosis is the responsibility of the prescribing or treating healthcare professional. The ZEUS Platform is indicated for use on patients 18 years or older who may be asymptomatic or who may suffer from symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety. The ZEUS Platform is not intended for detection or notification of hemodynamically unstable or life-threatening arrhythmias or cardiac events requiring urgent medical response. It is not intended for patients at elevated risk of serious cardiovascular events that would require immediate intervention.

Source page: https://510kreport.com/device/K252859
Methodology: https://510kreport.com/methodology