Not Cleared Post-NSE

DEN110011 - SYMPHONY DEVICE (FDA 510(k) Clearance)

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

DEN110011 · Sensory Medical, Inc. · Neurology device
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Dec 2013
Decision
889d
Days
Class 2
Risk

DEN110011 is an FDA 510(k) submission (not cleared) for the SYMPHONY DEVICE. Classified as Vibratory Counter-stimulation (product code OVP), Class II - Special Controls.

Submitted by Sensory Medical, Inc. (San Clemente, US). The FDA issued a Not Cleared (DENG) decision on December 18, 2013 after a review of 889 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5895 - 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 889 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 Sensory Medical, Inc. devices

Submission Details

510(k) Number DEN110011 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received July 13, 2011
Decision Date December 18, 2013
Days to Decision 889 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
741d slower than avg
Panel avg: 148d · This submission: 889d
Pathway characteristics

Device Classification

Product Code OVP Vibratory Counter-stimulation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5895
Definition A Vibratory Counter-stimulation Device Is A Prescription Device That Provides Electrically Powered Mechanical Vibration To Improve The Quality Of Sleep In Patients With Primary Restless Legs Syndrome.
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.