# K211709: Biotres

- Pathway: 510(k) (Traditional)
- Applicant: Biotricity
- Decided: Jan 19, 2022 after 230 days
- Product code: MWJ (Electrocardiograph, Ambulatory (Without Analysis))
- 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.
2 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171410: ePatch, Braemar Manufacturing, LLC (2018) Summary page 4.

## Most influential descendants
- K233864: ASSURE Wearable ECG (2024), 0 descendants of its own
- K222017: Biotres (2022), 0 descendants of its own

## Indications for use
The Biotres is indicated for use on adult patients 18 years or older who may be asymptomatic or who suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-syncope, syncope, fatigue, chest pain and/or anxiety and may require cardiac recording on a continuous basis for up to 30 days. The signal acquired by the Biotres is not intended and should not be used for automated or semi-automated analysis.

Source page: https://510kreport.com/device/K211709
Methodology: https://510kreport.com/methodology