MJC
10 FDA 510(k) clearances · Product code
216 daysmedian time to decision
1302 days90th percentile
10clearances measured
FDA profile
- Official device name
- Catheter, Urological (Antimicrobial) And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Medical specialty
- Gastroenterology, Urology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2021: 1,464 · 2022: 1,796 · 2023: 1,987 · 2024: 1,960 · 2025: 3,809 · 2026: 1,090
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Wellead® Latex Foley Catheter (K233094) | Well Lead Medical (Hainan) Co., Ltd. | 2024-06-06 |
| BARDEX I.C. LATEX FOLEY CATHETER (K040658) | C.R. Bard, Inc. | 2004-09-29 |
| HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT (K033477) | Rochester Medical Corp. | 2004-06-10 |
| SPECTRUM SILICONE FOLEY CATHETER (K000251) | Cook Urological, Inc. | 2000-08-30 |
| RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER (K001143) | Rochester Medical Corp. | 2000-07-07 |
| BARDEX I.C. PEDIATRIC FOLEY CATHETER (K993464) | C.R. Bard, Inc. | 1999-12-10 |
| BARDEX LUBRI-SIL I.C. FOLEY CATHETER (K984136) | Bard Medical Div. | 1999-02-16 |
| BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24 (K983101) | C.R. Bard, Inc. | 1998-11-03 |
| SILICONE ANTIBACTERIAL FOLEY CATHETER (K971627) | Rochester Medical Corp. | 1998-01-13 |
| BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER (K910318) | C.R. Bard, Inc. | 1994-08-18 |
Track MJC automatically
Every clearance here is in the API, with alerts when new ones post.