FDA product code QEA: Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
QEA is the FDA product code for brain injury adjunctive interpretive oculomotor assessment aid. It is a Class II device, regulated under 21 CFR 882.1455 and reviewed by the Neurology panel. FDA has cleared 6 510(k) submissions under QEA, 2 in the last five years, from 2 different applicants. The average 510(k) review took 184 days (median 160); 214 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 2 recalls for QEA devices, 1 initiated in the last five years.
Definition
A traumatic brain injury eye movement assessment aid is a prescription device that uses a patients tracked eye movements to provide an interpretation of the functional condition of the patients brain. This device is an assessment aid that is not intended for standalone detection or diagnostic purposes.
Classification
| Field | Value |
|---|---|
| Device name | Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid |
| Device class | Class II |
| Regulation | 21 CFR 882.1455 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for QEA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 90 |
| 2020 | 1 | 66 |
| 2021 | 2 | 260 |
| 2025 | 1 | 259 |
| 2026 | 1 | 169 |
Compare with all 510(k) review times · Search every QEA clearance
Top QEA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Oculogica, Inc. | 5 | 2026-06-05 |
| Syncthink, Inc. | 1 | 2021-10-02 |
Most recent QEA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254086 | Oculogica, Inc. | EyeBOX SNAP | 2026-06-05 | 169 |
| K242116 | Oculogica, Inc. | EyeBOX EBX-4.1 | 2025-04-04 | 259 |
| K212310 | Oculogica, Inc. | EyeBOX (Model EBX-4) | 2021-12-22 | 152 |
| K202927 | Syncthink, Inc. | EYE-SYNC | 2021-10-02 | 368 |
| K201841 | Oculogica, Inc. | EyeBOX | 2020-09-06 | 66 |
Recalls for QEA devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-09-19.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code QEA?
QEA is the FDA product code for brain injury adjunctive interpretive oculomotor assessment aid. It is a Class II device, regulated under 21 CFR 882.1455 and reviewed by the Neurology panel.
What device class is QEA?
Class II, regulation 21 CFR 882.1455. Typical premarket route: 510(k).
How long does a 510(k) take for product code QEA?
Across 6 cleared submissions the average was 184 days from receipt to decision (median 160).
Which companies have the most QEA clearances?
Oculogica, Inc. (5); Syncthink, Inc. (1).
Have QEA devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2023-09-19.
Next steps
- Run an FDA pathway report with predicate devices for product code QEA
- Run a recall and safety report across every QEA manufacturer
- Watch product code QEA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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