Not Cleared Direct

DEN240064 - CT-132 (FDA 510(k) Clearance)

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

DEN240064 · Click Therapeutics, Inc. · Neurology device
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Apr 2025
Decision
150d
Days
Class 2
Risk

DEN240064 is an FDA 510(k) submission (not cleared) for the CT-132. Classified as Computerized Behavioral Therapy Device For Migraine (product code SEE), Class II - Special Controls.

Submitted by Click Therapeutics, Inc. (New York, US). The FDA issued a Not Cleared (DENG) decision on April 11, 2025 after a review of 150 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5806 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Neurology review framework.

View all Click Therapeutics, Inc. devices

Submission Details

510(k) Number DEN240064 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received November 12, 2024
Decision Date April 11, 2025
Days to Decision 150 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 148d · This submission: 150d
Pathway characteristics

Device Classification

Product Code SEE Computerized Behavioral Therapy Device For Migraine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5806
Definition A Computerized Behavioral Therapy Device For Headache Is A Prescription Device Intended To Provide A Computerized Version Of Behavioral Therapy For The Treatment Of Headache.
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.