# FGD: Catheter, Retention, Barium Enema With Bag

- Device class: 2; regulation: 21 CFR 876.5980; FDA's rule: 510(k) exempt
- FDA decisions: 6
- 510(k) review time 2021–2025: median 171 days (middle half 171–171)
- 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
- 1989: 1
- 1990: 1
- 1991: 2
- 2023: 1

## Most-cited predicates
- K884379: Maglinte Enteroclysis Catheter (1989), cited by 1

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