FDA Product Code QEA: Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
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.
Leading manufacturers include Oculogica, Inc. and Syncthink, Inc..
7
Total
6
Cleared
211d
Avg days
2018
Since
Growing category -
2 submissions in the last 2 years
vs 0 in the prior period
Consistent review times:
214d avg (recent)
FDA 510(k) Cleared Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid Devices (Product Code QEA)
7 devices
Cleared
Jun 05, 2026
EyeBOX SNAP
Oculogica, Inc.
Neurology
169d
Cleared
Apr 04, 2025
EyeBOX EBX-4.1
Oculogica, Inc.
Neurology
259d
Cleared
Dec 22, 2021
EyeBOX (Model EBX-4)
Oculogica, Inc.
Neurology
152d
Cleared
Oct 02, 2021
EYE-SYNC
Syncthink, Inc.
Neurology
368d
Cleared
Sep 06, 2020
EyeBOX
Oculogica, Inc.
Neurology
66d
Cleared
Jul 31, 2019
EyeBOX
Oculogica, Inc.
Neurology
90d
Not Cleared
Dec 28, 2018
EyeBOX
Oculogica, Inc.
Neurology
371d
About Product Code QEA - Regulatory Context
510(k) Submission Activity
7 total 510(k) submissions under product code QEA since 2018, with 6 receiving FDA clearance (average review time: 211 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - QEA Product Code
FDA review times for QEA submissions have been consistent, averaging 214 days recently vs 209 days historically.
QEA devices are reviewed by the Neurology panel. Browse all Neurology devices →