# K982090: Paceart Home Trak Plus Easi Event Recorder System

- Pathway: 510(k) (Traditional)
- Applicant: Paceart, Inc.
- Decided: Jan 26, 1999 after 225 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 K930806 (1994). 5 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 12 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.
- K915632: Paceart CPTS-86/12, Paceart, Inc. (1992) Summary page 1.
- K955015: Zymed Holter Scanner Model 2010, Zymed Medical Instrumentation (1996) Summary page 1.
- K872781: Easi Lead System Cable Assembly, Totemite Medical Electronics (1987) Summary page 1.

## Most influential descendants
- K020213: Netlink/Netscan (2002), 4 descendants of its own
- K042002: Synescope, Easyscope, Synecom, Holterreader (2004), 3 descendants of its own
- K193177: CER-S (2020), 2 descendants of its own
- K213861: CER-S (2022), 1 descendant of its own
- K250258: HeartBeam AIMIGo with 12-L ECG Synthesis Software System (2025), 0 descendants of its own

## Indications for use
The HomeTrak Plus Cardiac Twelve-Lead Event Recorder is a patient-activated ambulatory cardiac event monitor and associated central-station receiving equipment which are to be used for recording infrequent and elusive heart arrhythmias and transmitting them by telephone at a later time to a central analysis center. It records three electrocardiographic leads and derives 12 electrocardiographic leads from the three transmitted, called the “EASI” system.

Source page: https://510kreport.com/device/K982090
Methodology: https://510kreport.com/methodology