# FZD: Prosthesis, Ear, Internal

- Device class: 2; regulation: 21 CFR 878.3590; FDA's rule: 510(k) required
- FDA decisions: 3
- 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)
- 1985: 1
- 1986: 1
- 2018: 1

## Most-cited predicates
- K863939: Porex (TM) Ear Prosthesis (1986), cited by 1

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