# K163535: my Patch sl

- Pathway: 510(k) (Special)
- Applicant: Dms-Service, LLC
- Decided: Feb 22, 2017 after 68 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: 5 generations back to K950944 (1996). 7 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160704: myPatch-s, Dms-Service, LLC (2016) Summary page 4.

## Most influential descendants
- K210758: Q Patch (2022), 1 descendant of its own
- K203168: LifeLens Wireless ECG Monitor (2021), 1 descendant of its own
- K260157: LifeLens Physiological Monitor (2026), 0 descendants of its own
- K252839: ZywieZ3 Sensor & Adhesive (2026), 0 descendants of its own
- K202456: M5 Recorder (2020), 0 descendants of its own

## Indications for use
myPatch®sl 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, chest pain and/or anxiety. The myPatch®sl is intended for use by Adults and all Pediatric subgroups

Source page: https://510kreport.com/device/K163535
Methodology: https://510kreport.com/methodology