# K201841: EyeBOX

- Pathway: 510(k) (Traditional)
- Applicant: Oculogica, Inc.
- Decided: Sep 6, 2020 after 66 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: 2 generations back to DEN170091 (2018). 2 ancestors in all.
3 later devices descend 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)
- K191183: EyeBOX, Oculogica, Inc. (2019) Summary page 4.

## Most influential descendants
- K212310: EyeBOX (Model EBX-4) (2021), 2 descendants of its own
- K242116: EyeBOX EBX-4.1 (2025), 1 descendant of its own
- 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), within one week of head injury in patients 5 through 67 years of age in conjunction with a standard neurological assessment of concussion. A negative EyeBOX classification may correspond to eye movement that is consistent with a lack of concussion. A positive EyeBOX classification corresponds to eye movement that may be present in both patients with or without concussion.

Source page: https://510kreport.com/device/K201841
Methodology: https://510kreport.com/methodology