# K052767: Afibalert Atrial Fibrillation Detector

- Pathway: 510(k) (Traditional)
- Applicant: Lechnologies Research, Inc.
- Decided: Jun 23, 2006 after 266 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: 2 generations back to K963725 (1997). 6 ancestors in all.
47 later devices descend from it; 3 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020825: King of Hearts Express + AF Monitor, Card Guard Scientific Survival, Ltd. (2002) Summary page 1.
- K012223: CG-2211 Selfcheck Ecg Transmitter, Card Guard Scientific Survival, Ltd. (2001)
- K010945: Heartcard, Model 5258, Instromedix (2001) Summary page 1.

## Most influential descendants
- K140933: Alivecor Heart Monitor (2014), 28 descendants of its own
- K142743: AliveCor Heart Monitor (2015), 19 descendants of its own
- K171816: Kardia Band System (2017), 12 descendants of its own
- K080337: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MQ1-2D (2008), 12 descendants of its own
- K132206: Melys Atrial Fibrillation Screening Monitor (2014), 7 descendants of its own

## Indications for use
The AfibAlertTM 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/K052767
Methodology: https://510kreport.com/methodology