# K242116: EyeBOX EBX-4.1

- Pathway: 510(k) (Traditional)
- Applicant: Oculogica, Inc.
- Decided: Apr 4, 2025 after 259 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: 4 generations back to DEN170091 (2018). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212310: EyeBOX (Model EBX-4), Oculogica, Inc. (2021) Summary page 5.
- K202927: Eye-Sync, Syncthink, Inc. (2021) Summary page 5.

## Most influential descendants
- K254086: EyeBOX SNAP (2026), 0 descendants of its own

## Indications for use
The EyeBOX is intended to measure and analyze eye movements as an aid in the diagnosis of concussion, also known as mild traumatic brain injury (mTBI), in patients 5 through 67 years of age in conjunction with a standard neurological assessment of concussion. A negative BOX score classification may correspond to eye movement that is consistent with a lack of concussion within one week of injury. A positive BOX score classification corresponds to eye movement that may be present in both patients with or without a concussion within one week of injury. The EyeBOX provides a set of eye-tracking metrics in relation to a reference database of uninjured individuals.

Source page: https://510kreport.com/device/K242116
Methodology: https://510kreport.com/methodology