Cleared Traditional

K201841 - EyeBOX (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K201841 · Oculogica, Inc. · Neurology device
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Sep 2020
Decision
66d
Days
Class 2
Risk

K201841 is an FDA 510(k) clearance 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 Cleared decision on September 6, 2020 after a review of 66 days - a notably fast clearance cycle.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Oculogica, Inc. devices

Submission Details

510(k) Number K201841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2020
Decision Date September 06, 2020
Days to Decision 66 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 148d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.