Not Cleared Direct

DEN130022 - NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR (FDA 510(k) Clearance)

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

DEN130022 · Eneura Therapeutics · Neurology device
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Dec 2013
Decision
283d
Days
Class 2
Risk

DEN130022 is an FDA 510(k) submission (not cleared) for the NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR. Classified as Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache (product code OKP), Class II - Special Controls.

Submitted by Eneura Therapeutics (Orono, US). The FDA issued a Not Cleared (DENG) decision on December 13, 2013 after a review of 283 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5808 - 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. Elevated predicate reliance profile. With 283 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.

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Submission Details

510(k) Number DEN130022 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 05, 2013
Decision Date December 13, 2013
Days to Decision 283 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 148d · This submission: 283d
Pathway characteristics

Device Classification

Product Code OKP Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5808
Definition Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache Delivers Brief Duration, Rapidly Alternating, Or Pulsed, Magnetic Fields That Are Externally Directed At Spatially Discrete Regions Of The Brain To Induce Electric Currents For The Treatment Of Migraine 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.