Cleared Traditional

K253612 - Acclarent AERA Eustachian Tube Balloon Dilation System (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K253612 · Acclarent, Inc. · Ear, Nose, Throat device
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Feb 2026
Decision
93d
Days
Class 2
Risk

K253612 is an FDA 510(k) clearance 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. (Irvine, US). The FDA issued a Cleared decision on February 19, 2026 after a review of 93 days - within the typical 510(k) review window.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Acclarent, Inc. devices

Submission Details

510(k) Number K253612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2025
Decision Date February 19, 2026
Days to Decision 93 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 89d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K253612.
ACCLARENT AERA Eustachian Tube Dilation System
K230742 · Acclarent, Inc. · Dec 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