# K203082: Insight Infrared Video Goggles

- Pathway: 510(k) (Traditional)
- Applicant: Vestibular First
- Decided: Nov 12, 2020 after 30 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: 3 generations back to K972243 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152112: VisualEyes, Interacoustics A/S (2015) Summary page 4.
- K072254: VN415M, VN415B, VO425M, V0425B, 2D-Vog Goggles, 2D-Vog System, Interacoustics A/S (2008) Summary page 5.

## Indications for use
The Insight Infrared Video Goggles are intended for viewing and recording eye movements in support of identifying vestibular disorders in patients. The device is intended for use only by a trained healthcare professional in an appropriate healthcare setting. This device provides no diagnoses nor does it provide diagnostic recommendations. The target population is 12+ years of age.

Source page: https://510kreport.com/device/K203082
Methodology: https://510kreport.com/methodology