Cleared Traditional

Acclarent AERA Eustachian Tube Balloon Dilation System

K253612 · Acclarent, Inc. · Ear, Nose, Throat

Feb 2026

Decision

93d

Days

Class 2

Risk

About This 510(k) Submission

K253612 is an FDA 510(k) clearance for the Acclarent AERA Eustachian Tube Balloon Dilation System, a Eustachian Tube Balloon Dilation Device (Class II — Special Controls, product code PNZ), submitted by Acclarent, Inc. (Irvine, US). The FDA issued a Cleared decision on February 19, 2026, 93 days after receiving the submission on November 18, 2025. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4180.

Submission Details

510(k) Number	K253612 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	PNZ — Eustachian Tube Balloon Dilation Device
Device Class	Class II — 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.