# MJC: Catheter, Urological (Antimicrobial) And Accessories

- Device class: 2; regulation: 21 CFR 876.5130; FDA's rule: 510(k) required
- FDA decisions: 10
- 510(k) review time 2021–2025: median 254 days (middle half 254–254)
- Recalls: 6 (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)
- 1994: 1
- 1998: 2
- 1999: 2
- 2000: 2
- 2004: 2
- 2024: 1

## Most-cited predicates
- K040658: Bardex I.C. Latex Foley Catheter (2004), cited by 3
- K910318: Bard (R) Hydrogel/Silver-Coated Foley Catheter (1994), cited by 2
- K233094: Wellead® Latex Foley Catheter (2024), cited by 1
- K001143: Release NF Antibacterial Foley Catheter, Antibacterial Personal Catheter (2000), cited by 1
- K000251: Spectrum Silicone Foley Catheter (2000), cited by 1

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