# K973141: Heart Access Plus Cardiac Event Recorder

- Pathway: 510(k) (Traditional)
- Applicant: Paceart, Inc.
- Decided: Nov 12, 1997 after 83 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 K923930 (1992). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923930: Electrocardiograph Transmitter, Tz Medical, Inc. (1992) Summary page 1.
- (no number) Ralin Heart-Aide Event recorder: named in the summary without a submission number

## Most influential descendants
- K012407: Paceart TX3 Cardiac Event Recorder (2001), 0 descendants of its own

## Indications for use
The event recorder, called the “Heart Access Plus,” 1is intended to be worn by the patient and to record a short period of electrocardiogram when the patient depresses a button upon sensing symptoms 1indicated to him by his physician. The unit is intended to be used in the patient’s home, place of work, or when traveling. Recordings are then to be transmitted telephonically to a central receiver, where they are printed as received and then can be interpreted by a physician. The unit also has a voice diary so that the patients can record notes of the circumstances when the event was recorded. The Heart RAccess Plus operates in the so-called “Looping” mode, in which it is always active, and in which it records an interval of one channel of cardiac activity pefore and an interval after the depression of the button; The durations of the intervals are programmable. The intended patient population 1s patients experiencing intermittent and unexpected cardiac events and arrhythmias.

Source page: https://510kreport.com/device/K973141
Methodology: https://510kreport.com/methodology