# K111745: King of Hearts Express AF Cardiac Event Recorder

- Pathway: 510(k) (Special)
- Applicant: Card Guard Scientific Survival, Ltd.
- Decided: Aug 1, 2011 after 41 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: 6 generations back to K963725 (1997). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 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.
- K101639: CG-6108 Act-IL Continuous Ecg Monitor and Arrythmia Detector, Card Guard Scientific Survival, Ltd. (2010) Summary page 1.

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

Source page: https://510kreport.com/device/K111745
Methodology: https://510kreport.com/methodology