# K162571: Bioflux Software

- Pathway: 510(k) (Traditional)
- Applicant: Biotricity, Inc.
- Decided: Oct 13, 2016 after 28 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: 9 generations back to K941811 (1994). 37 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122632: Guava II, Cardiocomm Solutions, Inc. (2014) Summary page 4.

## Most influential descendants
- K201040: Bioflux Software II (2020), 0 descendants of its own

## Indications for use
Bioflux software is intended to be used to analyze, view, and report ECG data acquired from a variety of ECG sources including single and 3-lead ECG devices. Bioflux software is operated locally in a browser and data is accessed via the users’ credentials on the hardware platform running the browser. It will be used by cardiologists, general practitioners, cardiac, or ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions, or care givers, in independent clinical testing facilities, clinics, hospitals, physician’s offices, or anywhere a physician or qualified non-physician practitioners deems appropriate Bioflux software does not offer diagnosis, or medical alarms. It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgement and experience are used to check and interpret the data.

Source page: https://510kreport.com/device/K162571
Methodology: https://510kreport.com/methodology