# K921068: Gikter Ecg Cassette Tape Recorder Model XR 300

- Pathway: 510(k) (Traditional)
- Applicant: Datrix
- Decided: Mar 30, 1992 after 24 days
- Product code: DSH (Recorder, Magnetic Tape, Medical)
- 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
No predicates in its family tree.
7 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K982975: Digital Ecg Holter Recorder, Model DR512 (1998), 5 descendants of its own
- 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

Source page: https://510kreport.com/device/K921068
Methodology: https://510kreport.com/methodology