# K173872: FibriCheck

- Pathway: 510(k) (Traditional)
- Applicant: Qompium NV
- Decided: Sep 28, 2018 after 282 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K963725 (1997). 8 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132206: Melys Atrial Fibrillation Screening Monitor, Advanced Fluidics, LLC (2014) Summary page 4.

## Most influential descendants
- K192415: Study Watch with Irregular Pulse Monitor (2020), 2 descendants of its own
- K232804: FibriCheck (2024), 1 descendant of its own
- K250233: PreemptiveAI Clinical SDK (2026), 0 descendants of its own
- K213357: Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor (2022), 0 descendants of its own
- K213409: ZEUS System (Zio Watch) (2022), 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/K173872
Methodology: https://510kreport.com/methodology