# PNZ: Eustachian Tube Balloon Dilation Device

- Device class: 2; regulation: 21 CFR 874.4180; FDA's rule: 510(k) required
- FDA decisions: 9
- 510(k) review time 2021–2025: median 147 days (middle half 137–251)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2016: 1
- 2017: 1
- 2018: 1
- 2021: 1
- 2022: 1
- 2023: 3
- 2026: 1

## Most-cited predicates
- K163509: XprESS ENT Dilation System (2017), cited by 5
- K171761: ACCLARENT AERA Eustachian Tube Balloon Dilation System (2018), cited by 4
- DEN150056: Acclarent Aera Eustachian Tube Balloon Dilation System (2016), cited by 2
- K230742: ACCLARENT AERA Eustachian Tube Dilation System (2023), cited by 1

Source page: https://510kreport.com/product-code/PNZ
Data by year (CSV): https://510kreport.com/product-code/PNZ.csv