# K042022: E-Tac EX-1000 Electrocardiographic Event Recorder

- Pathway: 510(k) (Traditional)
- Applicant: Datrix, Inc. Dba of Jon Barron, Inc.
- Decided: Aug 12, 2004 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). 3 ancestors in all.
42 later devices descend from it; 2 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920984: King of Hearts Express (E.X.) Monitor, Instromedix, Inc. (1992) Summary page 1.
- K923930: Electrocardiograph Transmitter, Tz Medical, Inc. (1992) Summary page 1.
- K981394: Braemar ER700 Series Ambulatory Ecg Event Monitor Models ER710,ER720, Braemar Corp. (1998) Summary page 1.

## Most influential descendants
- K090696: Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry System (2009), 40 descendants of its own
- K091971: Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT) System (2009), 38 descendants of its own
- K111917: Nuvant, Mobile Cardiac Telemetry (2011), 30 descendants of its own
- K113372: Nuvant, Mobilc Cardiac Telemetry (2012), 24 descendants of its own
- K133701: Nuvant MCT System (2014), 23 descendants of its own

## Indications for use
The Datrix E-Tac EX-1000 Electrocardiographic Event Recorder device is intended for long-term monitoring of ambulatory cardiac patients who experience intermittent symptoms associated with cardiac arrhythmia. Upon activation by the patient, ECG data are stored for future transmission via telephone to a receiving station. Data transmission is initiated by the patient and confirmed by the receiving station. Once data are transmitted, they are immediately available for review solely by a physician or other qualified medical professionals.

Source page: https://510kreport.com/device/K042022
Methodology: https://510kreport.com/methodology