# K254086: EyeBOX SNAP

- Pathway: 510(k) (Traditional)
- Applicant: Oculogica, Inc.
- Decided: Jun 5, 2026 after 169 days
- Product code: QEA (Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid)
- Device class: 2
- Regulation: 21 CFR 882.1455
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to DEN170091 (2018). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242116: EyeBOX EBX-4.1, Oculogica, Inc. (2025) Summary page 5.

## Indications for use
EyeBOX SNAP provides a multi-modal measure (SNAP Score) to aid in the diagnosis of concussion, also known as mild traumatic brain injury (mTBI), in patients 15 through 25 years of age, in conjunction with a clinical assessment. A negative SNAP Score classification corresponds to eye movements and symptom severity that are consistent with a lack of concussion within 3 days of injury. A positive SNAP Score classification corresponds to eye movements and symptom severity that may be present in patients with concussion within 3 days of injury. EyeBOX SNAP provides a set of eye-tracking metrics in relation to a reference database of uninjured individuals. These metrics can be used at any time.

Source page: https://510kreport.com/device/K254086
Methodology: https://510kreport.com/methodology