# K190593: Zio XT ECG Monitoring System, Zio AT ECG Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: iRhythm Technologies, Inc.
- Decided: Aug 23, 2019 after 169 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: 13 generations back to K882803 (1988). 54 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181502: Zio AT ECG Monitoring System, ZEUS System, iRhythm Technologies, Inc. (2018) Summary page 4.

## Most influential descendants
- K202527: Zio ECG Utilization Software (ZEUS) System (2021), 3 descendants of its own
- K222389: ZEUS System (2023), 1 descendant of its own
- K252859: ZEUS Platform (FG0501US) (2026), 0 descendants of its own
- K213409: ZEUS System (Zio Watch) (2022), 0 descendants of its own

## Indications for use
The Zio ECG Utilization Service (ZEUS) System is intended to analyze and report symptomatic and asymptomatic cardiac events and continuous electrocardiogram information for long-term monitoring. After patient monitoring by Zio XT or Zio AT Patch, a final report is generated based on the beat-to-beat information from the entire ECG recording. It 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/K190593
Methodology: https://510kreport.com/methodology