Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EXJ — Predicate Candidate Screening
22 FDA 510(k) clearances under this product code; the 50 most recent screened below.
62 daysmedian FDA review time
232 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K970465 | BOUSER'S URINAL | General Polymers | 1997-12-18 | 314 | 0 |
| K972100 | VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000) | Advanced Care Medical Products | 1997-07-31 | 57 | 0 |
| K970966 | COMFORT CATH CHOICE MALE EXTERNAL CATHETER | Sierra Laboratories, Inc. | 1997-04-22 | 36 | 0 |
| K963265 | PROSYS SAMEC LA | Convatec, A Division of E.R. Squibb & Sons | 1996-10-25 | 66 | 0 |
| K962900 | SELF RETAINING MALE EXTERNAL URINARY CATHETER | Hollister, Inc. | 1996-09-16 | 53 | 0 |
| K962384 | COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER | Sierra Laboratories, Inc. | 1996-07-15 | 25 | 0 |
| K962413 | COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER | Sierra Laboratories, Inc. | 1996-07-15 | 24 | 0 |
| K952082 | ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETE | Rochester Medical Corp. | 1995-07-18 | 76 | 0 |
| K945628 | CLEAR ADVANTAGE II | Mentor Corp. | 1995-07-06 | 232 | 0 |
| K951530 | PROSYS URIHESIVE SYSTEM LA | Convatec, A Division of E.R. Squibb & Sons | 1995-05-12 | 39 | 0 |
| K950690 | PROSYS URIHESICE SYSTEM NL | Convatec, A Division of E.R. Squibb & Sons | 1995-03-23 | 37 | 0 |
| K942941 | CONQUEST MALE CONTINENCE SYSTEM | Convatec, A Bristol-Myers Squibb Co. | 1995-03-17 | 268 | 0 |
| K946243 | CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER | Coloplast A/S | 1995-02-13 | 53 | 0 |
| K940269 | HOLLISTER NON-ROLLED SELF-ADHESIVE URINARY EXTERNAL CATHETER | Hollister, Inc. | 1994-06-02 | 132 | 0 |
| K934266 | COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER | Sierra Laboratories, Inc. | 1994-04-19 | 231 | 0 |
| K931156 | CONE CATH | Sierra Laboratories, Inc. | 1993-07-01 | 114 | 0 |
| K923136 | MALE EXTERNAL CATHETER | Rochester Medical Corp. | 1992-12-03 | 157 | 0 |
| K924407 | CONVEEN(R) SELF-SEALING URISHEATH MALE EXTER CATH | Coloplast A/S | 1992-09-23 | 29 | 0 |
| K913524 | SILICONE MALE EXTERNAL CATHETER | Mentor Corp. | 1991-10-04 | 57 | 0 |
| K903715 | CONDOM SEAL | Mark Sullivan, M.D., P.C. | 1991-01-23 | 162 | 0 |
| K851682 | SAFESEAL REUSABLE URINAL SYSTEM | Dbt Medical , Ltd. | 1985-06-24 | 62 | 0 |
| K772144 | CATHETER, DISP., EXTERNAL, MALE | Medline Industries, Inc. | 1977-11-28 | 13 | 0 |
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