Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MJC — Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
216 daysmedian FDA review time
1302 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233094 | Wellead® Latex Foley Catheter | Well Lead Medical (Hainan) Co., Ltd. | 2024-06-06 | 254 | 0 |
| K040658 | BARDEX I.C. LATEX FOLEY CATHETER | C.R. Bard, Inc. | 2004-09-29 | 201 | 7 |
| K033477 | HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTEN | Rochester Medical Corp. | 2004-06-10 | 220 | 1 |
| K000251 | SPECTRUM SILICONE FOLEY CATHETER | Cook Urological, Inc. | 2000-08-30 | 216 | 0 |
| K001143 | RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSO | Rochester Medical Corp. | 2000-07-07 | 88 | 0 |
| K993464 | BARDEX I.C. PEDIATRIC FOLEY CATHETER | C.R. Bard, Inc. | 1999-12-10 | 58 | 0 |
| K984136 | BARDEX LUBRI-SIL I.C. FOLEY CATHETER | Bard Medical Div. | 1999-02-16 | 90 | 1 |
| K983101 | BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22 | C.R. Bard, Inc. | 1998-11-03 | 61 | 0 |
| K971627 | SILICONE ANTIBACTERIAL FOLEY CATHETER | Rochester Medical Corp. | 1998-01-13 | 256 | 0 |
| K910318 | BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER | C.R. Bard, Inc. | 1994-08-18 | 1302 | 4 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda