# K010945: Heartcard, Model 5258

- Pathway: 510(k) (Traditional)
- Applicant: Instromedix
- Decided: Jun 12, 2001 after 75 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.
183 later devices descend from it; 4 cite it directly.
0 of 184 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K012223: CG-2211 Selfcheck Ecg Transmitter (2001), 181 descendants of its own
- K042254: PMP4 Selfcheck Ecg (2005), 99 descendants of its own
- K052767: Afibalert Atrial Fibrillation Detector (2006), 47 descendants of its own
- K060911: CG-6108 Arrhythmia Ecg Event Recorder (2006), 44 descendants of its own
- K071228: Fidelity 200 Cardiac Event Recorder (2007), 32 descendants of its own

Source page: https://510kreport.com/device/K010945
Methodology: https://510kreport.com/methodology