QEA · Class II · 21 CFR 882.1455

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 Patient’s Tracked Eye Movements To Provide An Interpretation Of The Functional Condition Of The Patient’s 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..

6
Total
5
Cleared
218d
Avg days
2018
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 259d recently vs 209d historically

FDA 510(k) Cleared Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid Devices (Product Code QEA)

6 devices
1–6 of 6
Cleared Apr 04, 2025
EyeBOX EBX-4.1
K242116
Oculogica, Inc.
Neurology · 259d
Cleared Dec 22, 2021
EyeBOX (Model EBX-4)
K212310
Oculogica, Inc.
Neurology · 152d
Cleared Oct 02, 2021
EYE-SYNC
K202927
Syncthink, Inc.
Neurology · 368d

About Product Code QEA - Regulatory Context

510(k) Submission Activity

6 total 510(k) submissions under product code QEA since 2018, with 5 receiving FDA clearance (average review time: 218 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under QEA have taken an average of 259 days to reach a decision - up from 209 days historically. Manufacturers should account for longer review timelines in current project planning.

QEA devices are reviewed by the Neurology panel. Browse all Neurology devices →