# K132206: Melys Atrial Fibrillation Screening Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Fluidics, LLC
- Decided: Mar 19, 2014 after 246 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: 3 generations back to K963725 (1997). 7 ancestors in all.
7 later devices descend from it; 1 cites 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)
- K052767: Afibalert Atrial Fibrillation Detector, Lechnologies Research, Inc. (2006) Summary page 1.

## Most influential descendants
- K173872: FibriCheck (2018), 6 descendants of its own
- 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

## Indications for use
The Melys Atrial Fibrillation Monitor 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/K132206
Methodology: https://510kreport.com/methodology