# EZC: Catheter, Coude

- Device class: 2; regulation: 21 CFR 876.5130; FDA's rule: 510(k) required
- FDA decisions: 7
- 510(k) review time 2021–2025: median 31 days (middle half 31–31)
- 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)
- 1991: 3
- 1992: 1
- 1995: 1
- 2018: 1
- 2022: 1

## Most-cited predicates
- K910195: Bard Hydrogel-Coated Foley Catheters (1991), cited by 2
- K910846: Bard Latex Urinary Catheters Drains- Designs Modif (1991), cited by 1
- K173596: Rusch Intermittent Urethral Catheters (2018), cited by 1
- K910197: Hydrogel-Coated Urethral Catheters and Drains (1991), cited by 1

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