# K023418: Heartone Event Recorder and Transmitter

- Pathway: 510(k) (Special)
- Applicant: Aerotel Medical Systems (1998), Ltd.
- Decided: Nov 6, 2002 after 26 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: 1 generation back to K931020 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931020: HEART 1001, Aerotel, Ltd. (1995) Summary page 1.

## Indications for use
The HeartOne is intended to be used as a Patient/physician activated single lead ECG data recorder/transmitter, for recording ECGs and transmitting them over telephone lines to Aerotel's Heartline Receiving Station The unit is indicated whenever it is desired to have single-lead electrocardiograms of a patient. There are no known contraindications.

Source page: https://510kreport.com/device/K023418
Methodology: https://510kreport.com/methodology