# ETD: Tube, Tympanostomy

- Device class: 2; regulation: 21 CFR 874.3880; FDA's rule: 510(k) required
- FDA decisions: 116
- 510(k) review time 2021–2025: median 93 days (middle half 90–136)
- Recalls: 13 (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)
- 2011: 1
- 2014: 1
- 2015: 3
- 2017: 1
- 2020: 1
- 2022: 1
- 2023: 1
- 2024: 2
- 2025: 1
- 2026: 1

## Most-cited predicates
- K830228: Otological Ventilation Tubes-Various (1983), cited by 5
- K943325: Tympanostomy Tube (1994), cited by 2
- K941407: Tympanostomy (Ventilation) Tube (1995), cited by 2
- K980828: Exmoor Myringotomy Kit (1998), cited by 2
- K822375: Armstrong V Vent Tube (1982), cited by 2
- K221254: Hummingbird Tympanostomy Tube System (2022), cited by 2
- K791680: Pope Umbrella Tube (1979), cited by 2
- K200952: Hummingbird Tympanostomy Tube System (2020), cited by 2
- K062385: Blue Ptfe (Fluoroplastic) Ventilation Tubes (2006), cited by 1
- K802587: Otological Ventilation Tubes (1980), cited by 1

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