510(k) · Cleared
Recalled · Class II · 2023Eye-Sync
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Syncthink, Inc. · QEA Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
Cleared on Oct 2, 2021 as substantially equivalent to DEN170091 (Oculogica, Inc., 2018) after a 368-day review. Its family tree reaches back 1 generation to 2018. 2 later devices descend from it. It has been recalled once.
- Decided
- Oct 2, 2021
- Review
- 368 days
- Class
- Class II
- Product code
- QEA
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN170091 (2018). 2 later devices descend from it, 1 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN170091 | EyeBOX | Oculogica, Inc. | 2018 | — |
| 0 (this device) | K202927 | Eye-Sync | Syncthink, Inc. | 2021 | — |
| +1 | K242116 | EyeBOX EBX-4.1 | Oculogica, Inc. | 2025 | — |
| +2 | K254086 | EyeBOX SNAP | Oculogica, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | DEN170091 | EyeBOXSummary page 4…Assessment Aid Regulation: 882.1455 Classification Panel: Neurology Device Class: 2 Product Code: QEA Predicate Device: Oculogica EyeBOX (DEN170091) Reference Devices: SyncThink EYE-SYNC (K152915), GN Otometric 1068 A/S Type 1085 ICS Impulse (K151504) Intended Us… | 2018 |
| † | K152915 | Eye-Sync | 2016 |
| † | K151504 | ICS Impulse | 2015 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242116 | EyeBOX EBX-4.1 | 2025 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 19, 2023 | Class II | Z-2114-2025 | Device Design | Eye syncing issues causing the device to be inoperable. Unable to be repaired due to discontinuation of support for the Pico 2 platform, which was no longer in production or serviceable as of August 31, 2023. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2021, 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 EYE-SYNC® is intended for recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in human subjects. The EYE-SYNC® is intended to record, measure, and analyze eye movements as an aid in the diagnosis of concussion, also known as mild traumatic brain injury (mTBI), within three days of sport-related head injury in patients 17-24 years of age in conjunction with a standard neurological assessment, for use by…
Read the full statement (115 words)
The EYE-SYNC® is intended for recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in human subjects.
The EYE-SYNC® is intended to record, measure, and analyze eye movements as an aid in the diagnosis of concussion, also known as mild traumatic brain injury (mTBI), within three days of sport-related head injury in patients 17-24 years of age in conjunction with a standard neurological assessment, for use by medical professionals qualified to interpret the results of a concussion assessment examination.
A negative EYE-SYNC® classification corresponds to eye movements that are consistent with a lack of concussion.
A positive EYE-SYNC® classification corresponds to eye movements that may be present in patients with concussion.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K202927 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202927: Eye-Sync.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202927
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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