Not Cleared Direct

DEN140032 - Cereve Sleep System (FDA 510(k) Clearance)

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

DEN140032 · Cereve, Inc. · Neurology device
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May 2016
Decision
571d
Days
Class 2
Risk

DEN140032 is an FDA 510(k) submission (not cleared) for the Cereve Sleep System. Classified as Thermal System For Insomnia (product code PLU), Class II - Special Controls.

Submitted by Cereve, Inc. (Oakmont, US). The FDA issued a Not Cleared (DENG) decision on May 13, 2016 after a review of 571 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5700 - 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 571 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 Cereve, Inc. devices

Submission Details

510(k) Number DEN140032 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received October 20, 2014
Decision Date May 13, 2016
Days to Decision 571 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
423d slower than avg
Panel avg: 148d · This submission: 571d
Pathway characteristics

Device Classification

Product Code PLU Thermal System For Insomnia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5700
Definition A Thermal System For Insomnia Is A Prescription Device For Use In Patients With Insomnia That Is Used To Apply A Specified Temperature To The Skin Surface.
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.