Cleared Special

K170209 - ImPACT (FDA 510(k) Clearance)

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

K170209 · Impact Applications, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
30d
Days
Class 2
Risk

K170209 is an FDA 510(k) clearance for the ImPACT. Classified as Computerized Cognitive Assessment Aid For Concussion (product code POM), Class II - Special Controls.

Submitted by Impact Applications, Inc. (San Diego, US). The FDA issued a Cleared decision on February 23, 2017 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1471 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Impact Applications, Inc. devices

Submission Details

510(k) Number K170209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2017
Decision Date February 23, 2017
Days to Decision 30 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 148d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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.