FDA product code MJC: Catheter, Urological (Antimicrobial) And Accessories
MJC is the FDA product code for catheter, urological (antimicrobial) and accessories. It is a Class II device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 10 510(k) submissions under MJC, 1 in the last five years, from 5 different applicants. The average 510(k) review took 275 days (median 208); 254 days on average over the last three years. FDA has posted 23 recalls for MJC devices, 5 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Urological (Antimicrobial) And Accessories |
| Device class | Class II |
| Regulation | 21 CFR 876.5130 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MJC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 254 |
Compare with all 510(k) review times · Search every MJC clearance
Top MJC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| C.R. Bard, Inc. | 4 | 2004-09-29 |
| Rochester Medical Corp. | 3 | 2004-06-10 |
| Well Lead Medical (Hainan) Co., Ltd. | 1 | 2024-06-06 |
| Cook Urological, Inc. | 1 | 2000-08-30 |
| Bard Medical Div. | 1 | 1999-02-16 |
Most recent MJC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233094 | Well Lead Medical (Hainan) Co., Ltd. | Wellead® Latex Foley Catheter | 2024-06-06 | 254 |
| K040658 | C.R. Bard, Inc. | BARDEX I.C. LATEX FOLEY CATHETER | 2004-09-29 | 201 |
| K033477 | Rochester Medical Corp. | HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT | 2004-06-10 | 220 |
| K000251 | Cook Urological, Inc. | SPECTRUM SILICONE FOLEY CATHETER | 2000-08-30 | 216 |
| K001143 | Rochester Medical Corp. | RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER | 2000-07-07 | 88 |
Recalls for MJC devices
23 product recalls in 12 recall events; 5 initiated in the last five years and 14 still open. Most recent: 2026-06-25.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 2 |
| 2020 | 1 |
| 2021 | 8 |
| 2024 | 1 |
| 2025 | 3 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code MJC?
MJC is the FDA product code for catheter, urological (antimicrobial) and accessories. It is a Class II device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel.
What device class is MJC?
Class II, regulation 21 CFR 876.5130. Typical premarket route: 510(k).
How long does a 510(k) take for product code MJC?
Across 10 cleared submissions the average was 275 days from receipt to decision (median 208).
Which companies have the most MJC clearances?
C.R. Bard, Inc. (4); Rochester Medical Corp. (3); Well Lead Medical (Hainan) Co., Ltd. (1); Cook Urological, Inc. (1); Bard Medical Div. (1).
Have MJC devices been recalled?
Yes: 23 product recalls across 12 recall events; the most recent began 2026-06-25.
Next steps
- Run an FDA pathway report with predicate devices for product code MJC
- Run a recall and safety report across every MJC manufacturer
- Watch product code MJC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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