# K202927: Eye-Sync

- Pathway: 510(k) (Traditional)
- Applicant: Syncthink, Inc.
- Decided: Oct 2, 2021 after 368 days
- Product code: QEA (Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid)
- Device class: 2
- Regulation: 21 CFR 882.1455
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN170091 (2018). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN170091: EyeBOX, Oculogica, Inc. (2018) Summary page 4.

## Most influential descendants
- K242116: EyeBOX EBX-4.1 (2025), 1 descendant of its own
- K254086: EyeBOX SNAP (2026), 0 descendants of its own

## Recalls of this device
- Sep 19, 2023 · Class II · Z-2114-2025: Eye syncing issues causing the device to be inoperable. Unable to be repaired due to discontinuation of support for the Pico 2 platform, which was no longer in production or serviceable as of August 3

## 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. The EYE-SYNC® is intended to record, measure, and analyze eye movements as an aid in the diagnosis of concussion, also known as mild traumatic brain injury (mTBI), within three days of sport-related head injury in patients 17-24 years of age in conjunction with a standard neurological assessment, for use by medical professionals qualified to interpret the results of a concussion assessment examination. A negative EYE-SYNC® classification corresponds to eye movements that are consistent with a lack of concussion. A positive EYE-SYNC® classification corresponds to eye movements that may be present in patients with concussion.

Source page: https://510kreport.com/device/K202927
Methodology: https://510kreport.com/methodology