De Novo · Granted
GrantedEyeBOX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oculogica, Inc. · QEA Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
Granted on Dec 28, 2018 as a new device type through De Novo after a 371-day review. 6 later devices descend from it.
- Decided
- Dec 28, 2018
- Review
- 371 days
- Class
- Class II
- Product code
- QEA
- Recalls
- None
6 later devices descend from it, 2 citing it directly.
- This deviceDEN170091 EyeBOXOculogica, Inc. · 2018
- Descendant · cites it directly · 4 of its ownK191183 EyeBOXOculogica, Inc. · 2019
- Descendant · 2 generations on · 3 of its ownK201841 EyeBOXOculogica, Inc. · 2020
- Descendant · 3 generations on · 2 of its ownK212310 EyeBOX (Model EBX-4)Oculogica, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK202927 Eye-SyncSyncthink, Inc. · 2021 · Recalled
- Descendant · 2 generations on · 1 of its ownK242116 EyeBOX EBX-4.1Oculogica, Inc. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K191183EyeBOXOculogica, Inc. · 2019 · cites it directly4descendants
- K201841EyeBOXOculogica, Inc. · 2020 · 2 generations on3descendants
- K212310EyeBOX (Model EBX-4)Oculogica, Inc. · 2021 · 3 generations on2descendants
- K202927Eye-SyncSyncthink, Inc. · 2021 · cites it directly2descendants
- K242116EyeBOX EBX-4.1Oculogica, Inc. · 2025 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN170091 | EyeBOX | Oculogica, Inc. | 2018 | — |
| +1 | K191183 | EyeBOX | Oculogica, Inc. | 2019 | — |
| +2 | K201841 | EyeBOX | Oculogica, Inc. | 2020 | — |
| +3 | K212310 | EyeBOX (Model EBX-4) | Oculogica, Inc. | 2021 | — |
| +1 | K202927 | Eye-Sync | Syncthink, Inc. | 2021 | 1 |
| +2 | K242116 | EyeBOX EBX-4.1 | Oculogica, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QEA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QEA device
- #1 K242116 EyeBOX EBX-4.1score 13.0 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K191183 (Oculogica, Inc., 2019) has gone furthest, with 4 descendants of its own.
How does its category compare?
All QEA devicesQEA Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · QEA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QEA
Too few QEA 510(k)s in any year since 2007 to give a median.
Recalls per year · QEA
No recall names QEA since 2007.
Adverse event reports per year · QEA
No MAUDE report names QEA since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN170091 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN170091: EyeBOX.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN170091
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026