# K223542: TubaVent Balloon Dilatation System

- Pathway: 510(k) (Traditional)
- Applicant: Spiggle & Theis Medizintechnik GmbH
- Decided: Aug 3, 2023 after 251 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)
- K171761: ACCLARENT AERA Eustachian Tube Balloon Dilation System, Acclarent, Inc. (2018) Summary page 5.

## Indications for use
The TubaVent balloon dilatation system is intended to dilate the cartilaginous portion of the Eustachian tube for treatment of persistent obstructive Eustachian tube dysfunction in patients 18 years and older.

Source page: https://510kreport.com/device/K223542
Methodology: https://510kreport.com/methodology