# DEN170091: EyeBOX

- Pathway: De Novo (Direct)
- Applicant: Oculogica, Inc.
- Decided: Dec 28, 2018 after 371 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
No predicates in its family tree.
6 later devices descend from it; 2 cite 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)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K191183: EyeBOX (2019), 4 descendants of its own
- K201841: EyeBOX (2020), 3 descendants of its own
- K212310: EyeBOX (Model EBX-4) (2021), 2 descendants of its own
- K202927: Eye-Sync (2021), 2 descendants of its own
- K242116: EyeBOX EBX-4.1 (2025), 1 descendant of its own

## Indications for use
The EyeBOX is intended to measure and analyze eye movements as an aid in the diagnosis of concussion 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/DEN170091
Methodology: https://510kreport.com/methodology