# K210841: NuVent Eustachian Tube Dilation Balloon

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Xomed, Inc.
- Decided: Aug 16, 2021 after 147 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: 22 generations back to K936109 (1994). 88 ancestors in all.
No later device cites it as a predicate yet.
0 of 89 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.
- K171761: ACCLARENT AERA Eustachian Tube Balloon Dilation System, Acclarent, Inc. (2018) Summary page 4.

## Indications for use
The NuVent Eustachian Tube Dilation Balloon is indicated for use in patients 18 years and older who need treatment for persistent Eustachian tube dysfunction.

Source page: https://510kreport.com/device/K210841
Methodology: https://510kreport.com/methodology