Not Cleared Direct

DEN150056 - Acclarent Aera Eustachian Tube Balloo...

DEN150056 is the FDA 510(k) submission for Acclarent Aera Eustachian Tube Balloo... by Acclarent, Inc.. It is a Class 2 Ear, Nose, Throat device (product code PNZ) cleared through the Direct 510(k) pathway after a 284-day FDA review.

DEN150056 · Acclarent, Inc. · Ear, Nose, Throat device
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Sep 2016
Decision
284d
Days
Class 2
Risk

DEN150056 is an FDA 510(k) submission (not cleared) for the Acclarent Aera Eustachian Tube Balloon Dilation System. Classified as Eustachian Tube Balloon Dilation Device (product code PNZ), Class II - Special Controls.

Submitted by Acclarent, Inc. (Rmenlo Park, US). The FDA issued a Not Cleared (DENG) decision on September 16, 2016 after a review of 284 days.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4180 - the FDA ear, nose and throat 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 284 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 Acclarent, Inc. devices

Submission Details

510(k) Number DEN150056 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 07, 2015
Decision Date September 16, 2016
Days to Decision 284 days
Submission Type Direct
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
195d slower than avg
Panel avg: 89d · This submission: 284d
Pathway characteristics

Device Classification

Product Code PNZ Eustachian Tube Balloon Dilation Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4180
Definition The Device Is Intended For Use In Dilating The Cartilaginous Portion Of The Eustachian Tube For Treating Persistent Eustachian Tube Dysfunction.
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 Ear, Nose, Throat devices follow this clearance model.