# K964646: Video Eye Trakker

- Pathway: 510(k) (Traditional)
- Applicant: Micromedical Technologies, Inc.
- Decided: Jul 15, 1997 after 237 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K152112: VisualEyes (2015), 4 descendants of its own
- K163149: VisualEyes (2017), 2 descendants of its own
- K200534: VisualEyes (2020), 1 descendant of its own
- K223047: NeuroSwift Pro (2023), 0 descendants of its own
- K203082: Insight Infrared Video Goggles (2020), 0 descendants of its own

## Indications for use
The device is used to non-invasively record horizontal and vertical eye movements of patients during routine electronystagmography (ENG) testing of vestibular function using miniature video cameras and pupil tracking hardware. The device is an alternative to skin electrodes and a physiologic signal amplifier for monitoring eye position.

Source page: https://510kreport.com/device/K964646
Methodology: https://510kreport.com/methodology