# K240029: Zio AT® device (A100A1001)

- Pathway: 510(k) (Traditional)
- Applicant: iRhythm Technologies, Inc.
- Decided: Oct 21, 2024 after 291 days
- Product code: QYX (Outpatient Cardiac Telemetry)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K882803 (1988). 53 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163512: Zio AT ECG Monitoring System, iRhythm Technologies, Inc. (2017) Summary page 6.

## Most influential descendants
- K240177: Zio AT® device (A100A1001) (2024), 0 descendants of its own

## Indications for use
The Zio AT device is intended to capture and transmit symptomatic and asymptomatic cardiac events and record continuous electrocardiogram (ECG) data for long-term monitoring. 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. It is not intended for use on critical care patients.

Source page: https://510kreport.com/device/K240029
Methodology: https://510kreport.com/methodology