Not Cleared Direct

DEN170091 - EyeBOX (FDA 510(k) Clearance)

Class II Neurology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN170091 · Oculogica, Inc. · Neurology device
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Dec 2018
Decision
371d
Days
Class 2
Risk

DEN170091 is an FDA 510(k) submission (not cleared) for the EyeBOX. Classified as Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid (product code QEA), Class II - Special Controls.

Submitted by Oculogica, Inc. (New York, US). The FDA issued a Not Cleared (DENG) decision on December 28, 2018 after a review of 371 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1455 - the FDA neurology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 371 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Oculogica, Inc. devices

Submission Details

510(k) Number DEN170091 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 22, 2017
Decision Date December 28, 2018
Days to Decision 371 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
223d slower than avg
Panel avg: 148d · This submission: 371d
Pathway characteristics

Device Classification

Product Code QEA Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1455
Definition 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.