Not Cleared Direct

DEN140024 - cNEP Airway (FDA 510(k) Clearance)

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

DEN140024 · Sommetrics · Anesthesiology device
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Dec 2015
Decision
492d
Days
Class 2
Risk

DEN140024 is an FDA 510(k) submission (not cleared) for the cNEP Airway. Classified as External Airway (product code PMB), Class II - Special Controls.

Submitted by Sommetrics (San Diego, US). The FDA issued a Not Cleared (DENG) decision on December 23, 2015 after a review of 492 days.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5105 - the FDA anesthesiology and respiratory 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 492 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 DEN140024 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 18, 2014
Decision Date December 23, 2015
Days to Decision 492 days
Submission Type Direct
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
353d slower than avg
Panel avg: 139d · This submission: 492d
Pathway characteristics

Device Classification

Product Code PMB External Airway
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5105
Definition This Device Is Intended To Maintain Airway Patency Using Negative Pressure During Mild To Moderate Sedation.
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 Anesthesiology devices follow this clearance model.