Not Cleared Direct

DEN150037 - ImPACT Computerized Neurocognitive Concussion Management Aid (FDA 510(k) Clearance)

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

DEN150037 · Impact Applications, Inc. · Neurology device
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Aug 2016
Decision
377d
Days
Class 2
Risk

DEN150037 is an FDA 510(k) submission (not cleared) for the ImPACT Computerized Neurocognitive Concussion Management Aid. Classified as Computerized Cognitive Assessment Aid For Concussion (product code POM), Class II - Special Controls.

Submitted by Impact Applications, Inc. (Pittsburgh, US). The FDA issued a Not Cleared (DENG) decision on August 22, 2016 after a review of 377 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1471 - 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 377 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 Impact Applications, Inc. devices

Submission Details

510(k) Number DEN150037 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 11, 2015
Decision Date August 22, 2016
Days to Decision 377 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
229d slower than avg
Panel avg: 148d · This submission: 377d
Pathway characteristics

Device Classification

Product Code POM Computerized Cognitive Assessment Aid For Concussion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1471
Definition For Use As An Assessment Aid In The Management Of Concussion.
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.