# K113176: Mysense Heart

- Pathway: 510(k) (Traditional)
- Applicant: Cardiac Science Corporation
- Decided: Dec 21, 2011 after 54 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
Longest line of descent: 2 generations back to K950944 (1996). 3 ancestors in all.
16 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090363: Zio Patch, Model Z100, iRhythm Technologies, Inc. (2009) Summary page 1.
- K993618: DXP1000 Holter Recorder, Braemar Corp. (1999) Summary page 1.

## 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 mySense Heart is indicated for use with patients who experience transient symptoms such as syncope, palpitations, shortness of breath or chest pains.

Source page: https://510kreport.com/device/K113176
Methodology: https://510kreport.com/methodology