# FFP: Dilator, Rectal

- Device class: 1; regulation: 21 CFR 876.5450; FDA's rule: 510(k) exempt
- FDA decisions: 5
- 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)
- 1983: 1
- 1989: 1
- 1990: 2
- 1997: 1

## Most-cited predicates
- K894618: Inamed Rhemo-D (TM) Dilator (1990), cited by 1

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