# K031074: Digital Ambulatory Ecg (Holter) Recorder

- Pathway: 510(k) (Traditional)
- Applicant: Datrix
- Decided: Oct 15, 2003 after 194 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: 2 generations back to K921068 (1992). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982975: Digital Ecg Holter Recorder, Model DR512, Datrix (1998) Summary page 2.
- K993618: DXP1000 Holter Recorder, Braemar Corp. (1999) Summary page 2.

## Most influential descendants
- K112601: Intricon Datrix Sirona Event/ Holter Recorder (2011), 0 descendants of its own

## Indications for use
The VX3 digital Holter recorder is intended for the recording of ECG data collected from ambulatory patients. The recorder can collect data in the presence of implanted pacemaker pulses, and can detect and record the occurrence of signals characteristic of pacemaker pulses. The recorder is used under the order of a physician, who reviews the data after downloading and processing by a Holter playback system. The physician determines the presence of normal and abnormal ECG data as well as pacemaker pulses during the events of the patient’s daily activity.

Source page: https://510kreport.com/device/K031074
Methodology: https://510kreport.com/methodology