# K220027: Audion ET dilation system

- Pathway: 510(k) (Traditional)
- Applicant: Entellus Medical, Inc.
- Decided: Apr 12, 2022 after 97 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.
No later device cites it as a predicate yet.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163509: XprESS ENT Dilation System, Entellus Medical, Inc. (2017) Summary page 4.

## Indications for use
To dilate the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction in patients 18 years and older using a transnasal approach.

Source page: https://510kreport.com/device/K220027
Methodology: https://510kreport.com/methodology