# K171761: ACCLARENT AERA Eustachian Tube Balloon Dilation System

- Pathway: 510(k) (Traditional)
- Applicant: Acclarent, Inc.
- Decided: Jan 16, 2018 after 216 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: 21 generations back to K936109 (1994). 87 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 93 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN150056: Acclarent Aera Eustachian Tube Balloon Dilation System, Acclarent, Inc. (2016) Summary page 4.
- K163509: XprESS ENT Dilation System, Entellus Medical, Inc. (2017) Summary page 4.

## Most influential descendants
- 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
- K210841: NuVent Eustachian Tube Dilation Balloon (2021), 0 descendants of its own
- K201115: Next Generation Balloon Dilation System (2020), 0 descendants of its own

## 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.

Source page: https://510kreport.com/device/K171761
Methodology: https://510kreport.com/methodology