# KDH: Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration

- Device class: 2; regulation: 21 CFR 876.5980; FDA's rule: 510(k) required
- FDA decisions: 23
- Recalls: 1 (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)
- 1986: 1
- 1989: 1
- 1990: 3
- 1991: 3
- 1992: 4
- 1994: 1
- 1995: 1
- 1997: 2
- 1998: 1
- 1999: 1

## Most-cited predicates
- K951533: Easi-Lav Pediatric / Adult Gastric Lavage Kit (1995), cited by 1

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