# K012407: Paceart TX3 Cardiac Event Recorder

- Pathway: 510(k) (Special)
- Applicant: Paceart, Inc.
- Decided: Aug 14, 2001 after 15 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 K923930 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973141: Heart Access Plus Cardiac Event Recorder, Paceart, Inc. (1997) Summary page 1.

## Indications for use
The TX3 Cardiac Event Recorder, called the TX3, is intended to be worn by the patient and to record a short period of electrocardiogram when the patient depresses a button upon sensing symptoms indicated to him by his physician. It is indicated when such recordings are required for diagnosis. The intended patient population is patients experiencing intermittent and unexpected cardiac events and arrhythmias.

Source page: https://510kreport.com/device/K012407
Methodology: https://510kreport.com/methodology