# FAE: Prosthesis, Penile

- Device class: 2; regulation: 21 CFR 876.3630; FDA's rule: 510(k) required
- FDA decisions: 32
- Recalls: 2 (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)
- 1989: 1
- 1990: 4
- 1991: 2
- 1992: 2
- 1995: 2
- 1996: 1
- 2004: 1
- 2008: 1
- 2009: 1
- 2019: 2

## Most-cited predicates
- K953640: Duna II Penile Prosthesis (1995), cited by 2
- K040959: Mentor Genesis Penile Prosthesis (2004), cited by 1
- K900371: Mentor Modified Malleable Penile Prostheses (1990), cited by 1
- K082006: Ams Spectra Concealable Penile Prosthesis (2008), cited by 1
- K912935: Ams Malleable 600 and 600M Penile Prosthesis (1992), cited by 1
- K951716: Ams 650 Mallerable Peniel Prosthesis (1995), cited by 1

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