# K050098: Ddat Omt

- Pathway: 510(k) (Traditional)
- Applicant: Ddat (Uk), Ltd.
- Decided: May 23, 2005 after 125 days
- Product code: GWN (Nystagmograph)
- Device class: 2
- Regulation: 21 CFR 882.1460
- 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 K991497 (1999). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991497: Ics Medical Chartr Eng/VNG Diagnostic System, Ics Medical Corp. (1999) Summary page 1.

## Most influential descendants
- K062015: Chronos Vision Eye Tracking Device (C-Etd) (2006), 0 descendants of its own

## Indications for use
The DDAT OMT is intended to be used to observe, record and measure eye movements in patients during ocular motor testing. The DDAT OMT is intended for use by qualified medical personnel trained in the use of nystagmographs.

Source page: https://510kreport.com/device/K050098
Methodology: https://510kreport.com/methodology