# K020825: King of Hearts Express + AF Monitor

- Pathway: 510(k) (Special)
- Applicant: Card Guard Scientific Survival, Ltd.
- Decided: Apr 5, 2002 after 22 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: 1 generation back to K920984 (1992). 2 ancestors in all.
120 later devices descend from it; 11 cite it directly.
0 of 123 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920984: King of Hearts Express (E.X.) Monitor, Instromedix, Inc. (1992) Summary page 1.
- K983626: King of Hearts Express II & King of Hearts Express EZ II, Alaris Medical Systems, Inc. (1999) Summary page 1.

## Most influential descendants
- K052767: Afibalert Atrial Fibrillation Detector (2006), 47 descendants of its own
- K042108: Vista Plus (2005), 46 descendants of its own
- K071641: Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539) (2007), 40 descendants of its own
- K071655: Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538 (2007), 30 descendants of its own
- K140933: Alivecor Heart Monitor (2014), 28 descendants of its own

## Indications for use
This device is indicated for diagnostic evaluation of patlents who experience transient symptoms such as; Dizziness Palpitations Syncope Chest pain

Source page: https://510kreport.com/device/K020825
Methodology: https://510kreport.com/methodology