# K163512: Zio AT ECG Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: iRhythm Technologies, Inc.
- Decided: Jun 2, 2017 after 169 days
- Product code: QYX (Outpatient Cardiac Telemetry)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K882803 (1988). 52 ancestors in all.
18 later devices descend from it; 4 cite it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143513: ZIO SR ECG Monitoring Service, iRhythm Technologies, Inc. (2015) Summary page 6.
- K133701: Nuvant MCT System, Corventis, Inc. (2014) Summary page 6.

## Most influential descendants
- K181502: Zio AT ECG Monitoring System, ZEUS System (2018), 12 descendants of its own
- K210822: DeepRhythmAI (2022), 6 descendants of its own
- K190593: Zio XT ECG Monitoring System, Zio AT ECG Monitoring System (2019), 4 descendants of its own
- K241197: DeepRhythmAI (2024), 3 descendants of its own
- K202527: Zio ECG Utilization Software (ZEUS) System (2021), 3 descendants of its own

## Recalls of this device
- Sep 28, 2022 · Class II · Z-0183-2023: Ambulatory ECG monitoring system labeling update: 1) Clinically actionable arrhythmia notifications delayed until patient registration is complete; 2) Patches limited to 100 symptomatic and 500 asympt

## Indications for use
The Zio QX ECG Monitoring System is intended to capture, analyze and report symptomatic and asymptomatic cardiac events and continuous electrocardiogram (ECG) information for long-term monitoring. While continuously recording patient ECG, both patient-triggered and automatically detected arrhythmia events are transmitted to a monitoring center for reporting. After wear, a final report is generated based on 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. 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/K163512
Methodology: https://510kreport.com/methodology