# LIL: Monitor, Penile Tumescence

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 26
- 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)
- 1987: 1
- 1988: 2
- 1992: 1
- 1994: 1
- 1995: 2
- 1998: 1
- 1999: 1
- 2000: 1
- 2003: 1
- 2006: 3

## Most-cited predicates
- K941781: Rigiscan Plus Rigidity Assessment System (1994), cited by 2
- K936115: Cat-600 Penile Plethysmograph (1995), cited by 1
- K033126: Monarch 21 Penile Plethysmograph System (2003), cited by 1
- K851646: Vibrector (1985), cited by 1
- K000194: Digital Inflection Rigidometer (Dir) (2000), cited by 1
- K841202: Dacomed Rigiscan System (1984), cited by 1

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