Not Cleared Direct

Acclarent Aera Eustachian Tube Balloon Dilation System (DEN150056) - FDA 510(k) Clearance

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

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.

Regulatory Peers - PNZ Eustachian Tube Balloon Dilation Device

All 8
Devices cleared under the same product code (PNZ) and FDA review panel - the closest regulatory comparables to DEN150056.
Acclarent AERA Eustachian Tube Balloon Dilation System
K253612 · Acclarent, Inc. · Feb 2026
ACCLARENT AERA Eustachian Tube Dilation System
K230742 · Acclarent, Inc. · Dec 2023
TubaVent Balloon Dilatation System
K223542 · Spiggle & Theis Medizintechnik GmbH · Aug 2023
VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System
K230065 · Fiagon GmbH · May 2023
Audion ET dilation system
K220027 · Entellus Medical, Inc. · Apr 2022
NuVent Eustachian Tube Dilation Balloon
K210841 · Medtronic Xomed, Inc. · Aug 2021