# K152915: Eye-Sync

- Pathway: 510(k) (Traditional)
- Applicant: Syncthink, Inc.
- Decided: Jan 29, 2016 after 119 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 K925111 (1994). 4 ancestors in all.
1 later device descends from it; 1 cites 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)
- K070729: Balanceback Mobile Intuitive VNG System, Fall Prevention Technologies, LLC (2007) Summary page 4.

## Most influential descendants
- K181771: RightEye Vision System (2018), 0 descendants of its own

## Indications for use
The EYE-SYNC 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/K152915
Methodology: https://510kreport.com/methodology