510(k) · Cleared
ClearedEyeBOX SNAP
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
Cleared on Jun 5, 2026 as substantially equivalent to K242116 (Oculogica, Inc., 2025) after a 169-day review. Its family tree reaches back 5 generations to 2018.
- Decided
- Jun 5, 2026
- Review
- 169 days
- Class
- Class II
- Product code
- QEA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN170091 (2018). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backDEN170091 EyeBOXOculogica, Inc. · 2018
- 4 generations backK191183 EyeBOXOculogica, Inc. · 2019
- 3 generations backK201841 EyeBOXOculogica, Inc. · 2020
- 2 generations backK212310 EyeBOX (Model EBX-4)Oculogica, Inc. · 2021
- 1 generation backK242116 EyeBOX EBX-4.1Oculogica, Inc. · 2025
- This deviceK254086 EyeBOX SNAPOculogica, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN170091 | EyeBOX | Oculogica, Inc. | 2018 | — |
| −4 | K191183 | EyeBOX | Oculogica, Inc. | 2019 | — |
| −3 | K201841 | EyeBOX | Oculogica, Inc. | 2020 | — |
| −2 | K212310 | EyeBOX (Model EBX-4) | Oculogica, Inc. | 2021 | — |
| −1 | K242116 | EyeBOX EBX-4.1 | Oculogica, Inc. | 2025 | — |
| 0 (this device) | K254086 | EyeBOX SNAP | Oculogica, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
Sources: FDA 510(k) 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
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K242116 | EyeBOX EBX-4.1Summary page 5…ommon or Usual Name: EyeBOX SNAP Classification Name: Neurology Regulatory Class: Class II Product Code: QEA Predicate Device: Oculogica, Inc. EyeBOX, Model EBX-4.1, K242116 Device Description Oculogica’s EyeBOX SNAP is an eye-tracking device with custom software. The device is comprised of a handhel… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 1.2 years on median.
- 1 of the 6 ancestors has a recall of any class.
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. 2026, 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?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254086 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254086: EyeBOX SNAP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254086
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026