# K113862: Zio Patch

- Pathway: 510(k) (Special)
- Applicant: iRhythm Technologies, Inc.
- Decided: Feb 6, 2012 after 38 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.
16 later devices descend from it; 1 cites it directly.
0 of 17 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
- K131190: Mypatch (2013), 15 descendants of its own
- K160704: myPatch-s (2016), 14 descendants of its own
- K171410: ePatch (2018), 7 descendants of its own
- K163535: my Patch sl (2017), 5 descendants of its own
- K231289: S-Patch Ex Wearable ECG Patch (2023), 3 descendants of its own

## Indications for use
The Zio® Patch is a prescription only single patient use, continuous recording ECG monitor that can be worn for up to 14 days. It is indicated for use on patients who experience transient symptoms such as syncope, palpitations, shortness of breath, or chest pains.

Source page: https://510kreport.com/device/K113862
Methodology: https://510kreport.com/methodology