# EZN: Dilator, Catheter, Ureteral

- Device class: 2; regulation: 21 CFR 876.5470; FDA's rule: 510(k) required
- FDA decisions: 56
- 510(k) review time 2021–2025: median 236 days (middle half 146–325)
- Recalls: 12 (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)
- 2004: 1
- 2005: 2
- 2006: 1
- 2013: 2
- 2017: 1
- 2018: 4
- 2019: 1
- 2020: 1
- 2023: 1
- 2025: 1

## Most-cited predicates
- K130804: Uromax Ultra Balloon Dilatation Catheter (2013), cited by 4
- K970041: Ascend Balloon Dailation Catheter (1997), cited by 3
- K851144: Ureteral Dilation Set (1985), cited by 3
- K941853: Passport (1994), cited by 1
- K945576: Meadox Surgimed Noprofile (TM) Olbert Catheter System (R) (1995), cited by 1
- K905375: Accent DG Balloon Ureteral Dilator Set (1991), cited by 1
- K813278: Vpi Ureteral Dilatation Ballon Catheter (1981), cited by 1
- K170531: Ureteral Dilators and Percutaneous Nephrostomy Dilators (2017), cited by 1
- K980795: Urological Balloon Dilatation Catheter (1998), cited by 1
- K993840: Bard Uroforce Balloon Dilation Catheter (2000), cited by 1

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