# K232804: FibriCheck

- Pathway: 510(k) (Traditional)
- Applicant: Qompium NV
- Decided: Jun 7, 2024 after 269 days
- Product code: QME (Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate)
- Device class: 2
- Regulation: 21 CFR 870.2785
- 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 K963725 (1997). 9 ancestors in all.
1 later device descends from it; 1 cites 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)
- K173872: FibriCheck, Qompium NV (2018) Summary page 5.

## Most influential descendants
- K250233: PreemptiveAI Clinical SDK (2026), 0 descendants of its own

## Indications for use
FibriCheck is indicated for self-testing by patients who have been diagnosed with, or are susceptible to developing, atrial fibrillation and who would like to monitor and record their heart rhythms on an intermittent basis.

Source page: https://510kreport.com/device/K232804
Methodology: https://510kreport.com/methodology