Not Cleared Direct

DEN170023 - ThermoNeuroModulation Device, TNM Device (FDA 510(k) Clearance)

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

DEN170023 · Scion Neurostim, LLC · Neurology device
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Mar 2018
Decision
343d
Days
Class 2
Risk

DEN170023 is an FDA 510(k) submission (not cleared) for the ThermoNeuroModulation Device, TNM Device. Classified as Thermal Vestibular Stimulator For Headache (product code QAR), Class II - Special Controls.

Submitted by Scion Neurostim, LLC (Raleigh, US). The FDA issued a Not Cleared (DENG) decision on March 26, 2018 after a review of 343 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5893 - 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 343 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 Scion Neurostim, LLC devices

Submission Details

510(k) Number DEN170023 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 17, 2017
Decision Date March 26, 2018
Days to Decision 343 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
195d slower than avg
Panel avg: 148d · This submission: 343d
Pathway characteristics

Device Classification

Product Code QAR Thermal Vestibular Stimulator For Headache
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5893
Definition The Device Is Intended To Stimulate The Vestibular System Using Thermal Waveforms In The Ear Canals For 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.