Not Cleared Direct

DEN180041 - Monarch eTNS System (FDA 510(k) Clearance)

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

DEN180041 · Neurosigma, Inc. · Neurology device
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Apr 2019
Decision
263d
Days
Class 2
Risk

DEN180041 is an FDA 510(k) submission (not cleared) for the Monarch eTNS System. Classified as Transcutaneous Nerve Stimulator For Adhd (product code QGL), Class II - Special Controls.

Submitted by Neurosigma, Inc. (Los Angeles, US). The FDA issued a Not Cleared (DENG) decision on April 19, 2019 after a review of 263 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5898 - 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 263 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 Neurosigma, Inc. devices

Submission Details

510(k) Number DEN180041 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received July 30, 2018
Decision Date April 19, 2019
Days to Decision 263 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d slower than avg
Panel avg: 148d · This submission: 263d
Pathway characteristics

Device Classification

Product Code QGL Transcutaneous Nerve Stimulator For Adhd
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5898
Definition A Transcutaneous Electrical Nerve Stimulator For Attention Deficit Hyperactivity Disorder (adhd) Is A Prescription Device That Stimulates Transcutaneously Or Percutaneously Through Electrodes Placed On The Forehead.
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.