# LKY: Device, External Penile Rigidity

- Device class: 2; regulation: 21 CFR 876.5020; FDA's rule: 510(k) exempt
- FDA decisions: 87
- 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)
- 1994: 3
- 1996: 4
- 1997: 6
- 1998: 17
- 1999: 6
- 2000: 7
- 2001: 7
- 2002: 7
- 2003: 3
- 2004: 1

## Most-cited predicates
- K841257: Sta-Potent System (1984), cited by 8
- K901223: Vacuum Erection Device (Ved) (1990), cited by 6
- K960828: Pos-T-Vac B-10 Band Kit (1996), cited by 6
- K891125: Constrictor Ring for Penile Erection (1989), cited by 4
- K980291: Impower External Vacuum System (1998), cited by 2
- K981506: Restore Vacuum Erection Device, Confide Vacuum Erection Device, Pep (Penile Erection Program), Rely Vacuum Erection Dev) (1998), cited by 2
- K960342: Pos-T-Vac Avp-1000 & MVP-700 (1996), cited by 2
- K844445: Revive System (1985), cited by 2
- K902240: Vet (Vacuum Erection Technology) (1990), cited by 2
- K981343: Erco-Ribbon (1998), cited by 1

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