# KOD: Catheter, Urological

- Device class: 2; regulation: 21 CFR 876.5130; FDA's rule: 510(k) required
- FDA decisions: 238
- 510(k) review time 2021–2025: median 226 days (middle half 220–286)
- Recalls: 73 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2010: 1
- 2011: 2
- 2014: 1
- 2016: 2
- 2017: 1
- 2018: 6
- 2019: 1
- 2021: 1
- 2022: 2
- 2026: 1

## Most-cited predicates
- K000070: Flocath (2000), cited by 6
- K896750: Lofric (R), Lofric (R) Cath-Kit (1990), cited by 6
- K080881: Cure Catheter Closed System (2008), cited by 4
- K013483: Incare Advance; Intermittent Catheter, Plus Intermittent Catheter, Plus Kit (2002), cited by 4
- K000723: Hydrophilic Silicone Foley Catheter and Personal Catheter (Hydrophilic and Non-Hydrophilic) (2000), cited by 4
- K011965: Imager II Urology Torque Catheter, Model 40030X1, 40040X1, and 40050X1 (2001), cited by 3
- K022135: Ureteral Access Sheath Set (Uass) (2002), cited by 2
- K102527: Imager II Urology Torque Catheter (C1 Tip); Imager II Urology Torque Catheter (C2 Tip; Imager II Urology Torque Catheter (2010), cited by 2
- K896729: Nelaton-, Female - or Tiemann Catheter (1990), cited by 2
- K032710: Closed System Intermittent Catheterization Kit (2004), cited by 2

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