# K253612: Acclarent AERA Eustachian Tube Balloon Dilation System

- Pathway: 510(k) (Traditional)
- Applicant: Acclarent, Inc.
- Decided: Feb 19, 2026 after 93 days
- Product code: PNZ (Eustachian Tube Balloon Dilation Device)
- Device class: 2
- Regulation: 21 CFR 874.4180
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 23 generations back to K936109 (1994). 89 ancestors in all.
No later device cites it as a predicate yet.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230742: ACCLARENT AERA Eustachian Tube Dilation System, Acclarent, Inc. (2023) Summary page 5.

## Indications for use
The ACCLARENT AERA® Eustachian Tube Balloon Dilation System is intended to dilate the Eustachian tube for treatment of persistent Eustachian tube dysfunction in patients ages 18 and older. For patients ages 8-17 years, the ACCLARENT AERA® Eustachian Tube Balloon Dilation System, alone or in combination with adjunctive procedures, is intended to treat patients with objective signs of persistent obstructive Eustachian tube dysfunction from inflammatory pathology, resulting in chronic otitis media with effusion and are refractory to at least one surgical intervention for persistent obstructive Eustachian tube dysfunction.

Source page: https://510kreport.com/device/K253612
Methodology: https://510kreport.com/methodology