# FHA: Clamp, Penile

- Device class: 1; regulation: 21 CFR 876.5160; FDA's rule: 510(k) exempt
- FDA decisions: 11
- 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)
- 1978: 1
- 1987: 1
- 1989: 1
- 1990: 1
- 1995: 2
- 1996: 1
- 1997: 3
- 1998: 1

## Most-cited predicates
- K885323: Dacomed External Male Continence Device (1989), cited by 2
- K964580: Cap-Aid (Improved) (1997), cited by 1
- K954959: Cap-Aid (1995), cited by 1
- K952841: The Assistant (1995), cited by 1

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