# K121319: Zio Patch

- Pathway: 510(k) (Traditional)
- Applicant: iRhythm Technologies, Inc.
- Decided: Jul 18, 2012 after 77 days
- Product code: DSH (Recorder, Magnetic Tape, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
36 later devices descend from it; 3 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K143513: ZIO SR ECG Monitoring Service (2015), 30 descendants of its own
- K163512: Zio AT ECG Monitoring System (2017), 18 descendants of its own
- 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

## Indications for use
The Zio® Patch is a prescription-only, single-patient-use, continuously recording EGG monitor that can be worn up to 14 days. It is indicated for use on patients 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.

Source page: https://510kreport.com/device/K121319
Methodology: https://510kreport.com/methodology