# K072385: Heartevent, Model at

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Devices Pty, Ltd.
- Decided: Jan 11, 2008 after 140 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 K920984 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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 2.

## Indications for use
The heartEVENTAT is indicated for use by patients as directed by a physician, who experience transient symptoms that may suggest cardiac arrhythmia, conduction abnormalities or other rhythm disturbances that may result in shortness of breath, pre-syncope or palpitations.

Source page: https://510kreport.com/device/K072385
Methodology: https://510kreport.com/methodology