# K931020: HEART 1001

- Pathway: 510(k) (Traditional)
- Applicant: Aerotel, Ltd.
- Decided: Jan 11, 1995 after 684 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.
3 later devices descend from it; 3 cite it directly.
0 of 4 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
- K023418: Heartone Event Recorder and Transmitter (2002), 0 descendants of its own
- K980144: Heartview P12/8 Electrocardiograph Recorder and Transmitter (1998), 0 descendants of its own
- K953762: Heart 400 Ecg Transmitter (1996), 0 descendants of its own

Source page: https://510kreport.com/device/K931020
Methodology: https://510kreport.com/methodology