# K111160: Intricon Datrix Centauri MT Ambulatory Patient Ecg Telemetry System (Apets)

- Pathway: 510(k) (Traditional)
- Applicant: Intricon Datrix Corporation
- Decided: Aug 1, 2011 after 98 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K923930 (1992). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081444: Braemar Fusion Wireless - Ambulatory Ecg Arrhythmia Monitoring System, Braemar, Inc. (2008) Summary page 2.
- K042022: E-Tac EX-1000 Electrocardiographic Event Recorder, Datrix, Inc. Dba of Jon Barron, Inc. (2004) Summary page 2.

## Indications for use
The IntriCon Datrix Centauri MT Ambulatory Patient ECG Telemetry System (APETS) is intended for diagnostic evaluation of patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors, automatically generates an event triggered by an arrhythmia detection algorithm or manually by the patient, and automatically transmits the recorded cardiac activity associated with these symptoms for review by a licensed physician.

Source page: https://510kreport.com/device/K111160
Methodology: https://510kreport.com/methodology