Not Cleared Post-NSE

DEN120019 - CEFALY (FDA 510(k) Clearance)

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

DEN120019 · Stx-Med Sprl · Neurology device
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Mar 2014
Decision
453d
Days
Class 2
Risk

DEN120019 is an FDA 510(k) submission (not cleared) for the CEFALY. Classified as Stimulator, Nerve, Electrical, Transcutaneous, For Migraine (product code PCC), Class II - Special Controls.

Submitted by Stx-Med Sprl (Herstal, Liege, BE). The FDA issued a Not Cleared (DENG) decision on March 11, 2014 after a review of 453 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5891 - 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 453 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 Stx-Med Sprl devices

Submission Details

510(k) Number DEN120019 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 13, 2012
Decision Date March 11, 2014
Days to Decision 453 days
Submission Type Post-NSE
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
305d slower than avg
Panel avg: 148d · This submission: 453d
Pathway characteristics

Device Classification

Product Code PCC Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5891
Definition Used To Apply An Electrical Current To A Patient's Cranium Through Electrodes Placed On The Skin.
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.

Regulatory Peers - PCC Stimulator, Nerve, Electrical, Transcutaneous, For Migraine

All 17
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