# K203168: LifeLens Wireless ECG Monitor

- Pathway: 510(k) (Traditional)
- Applicant: LifeLens Technologies, Inc.
- Decided: Jul 20, 2021 after 270 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: 6 generations back to K950944 (1996). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163535: my Patch sl, Dms-Service, LLC (2017) Summary page 4.

## Most influential descendants
- K260157: LifeLens Physiological Monitor (2026), 0 descendants of its own

## Indications for use
LifeLens Wireless ECG Monitor 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 LifeLens Wireless ECG Monitor is intended for use by patients 18 years or older. The LifeLens Wireless ECG Monitor is not intended to be worn during defibrillation.

Source page: https://510kreport.com/device/K203168
Methodology: https://510kreport.com/methodology