# EXD: Irrigator, Ostomy

- Device class: 2; regulation: 21 CFR 876.5895; FDA's rule: 510(k) exempt
- FDA decisions: 12
- 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)
- 1977: 2
- 1979: 2
- 1981: 1
- 1982: 1
- 1983: 1
- 1984: 1
- 1987: 1
- 1990: 1
- 1992: 1
- 2012: 1

## Most-cited predicates
- K840268: Irrigation System (1984), cited by 1

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