# K982975: Digital Ecg Holter Recorder, Model DR512

- Pathway: 510(k) (Traditional)
- Applicant: Datrix
- Decided: Nov 10, 1998 after 76 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: 1 generation back to K921068 (1992). 2 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921068: Gikter Ecg Cassette Tape Recorder Model XR 300, Datrix (1992) Summary page 1.
- K945130: Braemar Model DL700 Ambulatory Electrocardiographic Recorder, Braemar Corp. (1995) Summary page 1.

## Most influential descendants
- K062007: DMS 300-7 (2006), 2 descendants of its own
- K062959: DMS 300-2, 300-3 and 300-4 (2006), 1 descendant of its own
- K031074: Digital Ambulatory Ecg (Holter) Recorder (2003), 1 descendant of its own
- K133014: DMS 300-2W Holter Ecg Recorder (2014), 0 descendants of its own
- K112601: Intricon Datrix Sirona Event/ Holter Recorder (2011), 0 descendants of its own

## Indications for use
The DR512 digital Holter recorder is intended for the recording and storage of long-term ECG data collected from ambulatory patients. 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 during the events of the patient’s daily activity.

Source page: https://510kreport.com/device/K982975
Methodology: https://510kreport.com/methodology