# K963904: P.H.D. - Personal Heart Device Model 5258

- Pathway: 510(k) (Traditional)
- Applicant: Heart Alert, Inc.
- Decided: May 15, 1997 after 227 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
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K050670: Sensor Mobile SM 100 Vitaphone 1001R Remos (2005), 5 descendants of its own
- K053378: Loop Recorder  Vitaphone, 3100 Series (2006), 2 descendants of its own
- K100383: Vitaphone. Model 100 BT (2010), 1 descendant of its own
- K082013: Clue Medical and Clue Medical Basic (2008), 1 descendant of its own
- K151013: Vitaphone Tele ECG Loop Recorder (2015), 0 descendants of its own

Source page: https://510kreport.com/device/K963904
Methodology: https://510kreport.com/methodology