# K201040: Bioflux Software II

- Pathway: 510(k) (Traditional)
- Applicant: Biotricity
- Decided: Jul 29, 2020 after 119 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: 10 generations back to K941811 (1994). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162571: Bioflux Software, Biotricity, Inc. (2016) Summary page 4.

## Indications for use
Bioflux Software 11 is intended to be used to view and annotate data acquired from diagnostic ECG sources of 1 to 3-leads. Bioflux Software Il is operated in a web browser and data is accessed via the users’ credentials on the hardware platform running the web browser. It will be used by cardiologists, general practitioners, cardiac, ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions. Bioflux Software II will be used in independent clinical testing facilities, clinics, hospitals, physician’s offices, or anywhere a physician or qualified practitioners deem appropriate. Bioflux Software 11 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/K201040
Methodology: https://510kreport.com/methodology