# LOB: Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 2
- 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)
- 1983: 1
- 1985: 1
- 1986: 2
- 1987: 1
- 1988: 2
- 1991: 1
- 1995: 1
- 1996: 1
- 1999: 2
- 2002: 1

## Most-cited predicates

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