# FHW: Device, Impotence, Mechanical/Hydraulic

- Device class: 3; regulation: 21 CFR 876.3350; FDA's rule: PMA required
- FDA decisions: 1
- Recalls: 3 (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)
- 2017: 2
- 2018: 2
- 2019: 3
- 2020: 4
- 2021: 2
- 2022: 3
- 2023: 3
- 2024: 3
- 2025: 2
- 2026: 4

## Most-cited predicates

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