# K181771: RightEye Vision System

- Pathway: 510(k) (Traditional)
- Applicant: Righteye, LLC
- Decided: Sep 28, 2018 after 87 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: 4 generations back to K925111 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152915: Eye-Sync, Syncthink, Inc. (2016) Summary page 4.

## Indications for use
The RightEye Vision System is intended for recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in human subjects.

Source page: https://510kreport.com/device/K181771
Methodology: https://510kreport.com/methodology