# EZQ: Pouch, Colostomy

- Device class: 1; regulation: 21 CFR 876.5900; FDA's rule: 510(k) exempt
- FDA decisions: 6
- Recalls: 5 (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
- 1988: 1
- 1992: 1
- 2010: 2
- 2011: 1

## Most-cited predicates
- K083785: Vitala Continence Control Device (2010), cited by 2
- K863830: Conseal (TM) Colostomy Continence System (1986), cited by 1
- K102536: Vitala Continence Control Device (2010), cited by 1

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