# DEN150056: Acclarent Aera Eustachian Tube Balloon Dilation System

- Pathway: De Novo (Direct)
- Applicant: Acclarent, Inc.
- Decided: Sep 16, 2016 after 284 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
No predicates in its family tree.
10 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K163509: XprESS ENT Dilation System (2017), 9 descendants of its own
- K171761: ACCLARENT AERA Eustachian Tube Balloon Dilation System (2018), 5 descendants of its own
- K230742: ACCLARENT AERA Eustachian Tube Dilation System (2023), 1 descendant of its own
- K253612: Acclarent AERA Eustachian Tube Balloon Dilation System (2026), 0 descendants of its own
- K223542: TubaVent Balloon Dilatation System (2023), 0 descendants of its own

## Indications for use
indicated to dilate the Eustachian tube for treatment of persistent Eustachian tube dysfunction in adults ages 22 and older.

Source page: https://510kreport.com/device/DEN150056
Methodology: https://510kreport.com/methodology