510(k) · Cleared
ClearedEyeBOX
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 Sep 6, 2020 as substantially equivalent to K191183 (Oculogica, Inc., 2019) after a 66-day review. Its family tree reaches back 2 generations to 2018. 3 later devices descend from it.
- Decided
- Sep 6, 2020
- Review
- 66 days
- Class
- Class II
- Product code
- QEA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN170091 (2018). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backDEN170091 EyeBOXOculogica, Inc. · 2018
- 1 generation backK191183 EyeBOXOculogica, Inc. · 2019
- This deviceK201841 EyeBOXOculogica, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK212310 EyeBOX (Model EBX-4)Oculogica, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK242116 EyeBOX EBX-4.1Oculogica, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK254086 EyeBOX SNAPOculogica, Inc. · 2026
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN170091 | EyeBOX | Oculogica, Inc. | 2018 | — |
| −1 | K191183 | EyeBOX | Oculogica, Inc. | 2019 | — |
| 0 (this device) | K201841 | EyeBOX | Oculogica, Inc. | 2020 | — |
| +1 | K212310 | EyeBOX (Model EBX-4) | Oculogica, Inc. | 2021 | — |
| +2 | K242116 | EyeBOX EBX-4.1 | Oculogica, Inc. | 2025 | — |
| +3 | K254086 | EyeBOX SNAP | Oculogica, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K191183 | EyeBOXSummary page 4…484-393-2694 Subject Device Name: EyeBOX, Model OCL 02.5 Predicate Device Name: EyeBOX, Model OCL 02, K191183 Regulation Number: 21 CFR 882.1455 Regulation Name: Traumatic brain injury eye movement… | 2019 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212310 | EyeBOX (Model EBX-4) | 2021 | 2 |
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 2 years and passes through 1 company; a new generation was cleared every 1.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K212310 (Oculogica, Inc., 2021) has gone furthest, with 2 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. 2020, 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, 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201841 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201841: EyeBOX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201841
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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