# K112601: Intricon Datrix Sirona Event/ Holter Recorder

- Pathway: 510(k) (Traditional)
- Applicant: Intricon Datrix Corporation
- Decided: Nov 9, 2011 after 63 days
- Product code: MWJ (Electrocardiograph, Ambulatory (Without Analysis))
- Device class: 2
- Regulation: 21 CFR 870.2800
- 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 K921068 (1992). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071011: Modification to: Braemar ER900 Series Enhanced Algorithm Ecg Event Recorder, Braemar, Inc. (2007) Summary page 1.
- K072008: Braemar ER900 Wireless Series Arrhythmia Event Recorder, Braemar, Inc. (2007) Summary page 1.
- K031074: Digital Ambulatory Ecg (Holter) Recorder, Datrix (2003) Summary page 1.

## Indications for use
The IntriCon Datrix Sirona is a combination Event Recorder and Holter Recorder that is intended for diagnostic evaluation of patients who experience transient symptoms that may suggest cardiac arrhythmia. In the Event Recorder mode, once event data is recorded, patients transmit the recorded ECG data over the telephone or directly to a host PC for review by a licensed physician. In the Holter Recorder mode, the device is intended for the recording of ECG data collected from ambulatory patients. The data is then reviewed by the physician after downloading and processing by a Holter playback system.

Source page: https://510kreport.com/device/K112601
Methodology: https://510kreport.com/methodology