# KOB: Catheter, Suprapubic (And Accessories)

- Device class: 2; regulation: 21 CFR 876.5090; FDA's rule: 510(k) required
- FDA decisions: 32
- 510(k) review time 2021–2025: median 253 days (middle half 253–253)
- Recalls: 64 (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)
- 1992: 1
- 1995: 3
- 1997: 2
- 2001: 1
- 2002: 1
- 2012: 1
- 2014: 1
- 2018: 2
- 2019: 1
- 2024: 1

## Most-cited predicates
- K014002: All Silicone Supra-Pubia Catheter, Models 4880/4890 (2002), cited by 2
- K970021: Rusch Suprapubic Tray (1997), cited by 2
- K132890: Suprapubic Catheter and Introducer Set (2014), cited by 1
- K810368: Vance Percutaneous Malecot Nephrostomy (1981), cited by 1
- K884061: Add-a-Cath (1988), cited by 1
- K952187: Rusch Supraflex Suprapubic Cystostomy Catheter Kit, Sterile (1995), cited by 1
- K181097: Cook Cystostomy Catheter Set (2019), cited by 1

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