Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EZN — Predicate Candidate Screening
56 FDA 510(k) clearances under this product code; the 50 most recent screened below.
80 daysmedian FDA review time
225 days90th percentile
56clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250910 | Optilume® High Pressure Urological Balloon Dilation Catheter | Urotronic, Inc. | 2025-05-22 | 57 | 0 |
| K220781 | ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dila | Allwin Medical Devices, Inc. | 2023-05-05 | 414 | 0 |
| K201007 | In-Ka Ureteral Balloon Dilatation Catheter | Coloplast Corp. | 2020-06-11 | 55 | 0 |
| K190612 | EQUINOX Balloon Dilatation Catheter | Dornier Medtech America, Inc. | 2019-12-06 | 270 | 0 |
| K173654 | Ureteral Dilator Sets, Ureteral Dilators | Cook Incorporated | 2018-07-17 | 231 | 0 |
| K180756 | Safety Wire Guide Introducer | Cook Incorporated | 2018-05-24 | 63 | 0 |
| K180028 | Cook 810 Set, Desilets-Hoffman Introducer Set | Cook Incorporated | 2018-05-02 | 119 | 0 |
| K172588 | Balloon Catheter and Balloon Ureteral Dilator Set | Cook Incorporated | 2018-04-19 | 233 | 0 |
| K170531 | Ureteral Dilators and Percutaneous Nephrostomy Dilators | Coloplast Corp. | 2017-08-17 | 176 | 1 |
| K132181 | GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER | Olympus Surgical Technologies America | 2013-10-21 | 98 | 0 |
| K130804 | UROMAX ULTRA BALLOON DILATATION CATHETER | Boston Scientific Corporation | 2013-05-22 | 58 | 1 |
| K061009 | PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEU | Onset Medical Corporation | 2006-05-02 | 20 | 9 |
| K050875 | U-BALLOON DILATION CATHETER | C.R. Bard, Inc. | 2005-05-26 | 50 | 0 |
| K043254 | PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL | Onset Medical Corporation | 2005-02-10 | 78 | 0 |
| K040127 | COOK URETERAL BALLOON DILATION CATHETER SET | Cook Urological, Inc. | 2004-04-06 | 76 | 0 |
| K030662 | PATHWAY ACCESS SHEATH CATHETER | Vertelink Corporation | 2003-09-03 | 184 | 0 |
| K993840 | BARD UROFORCE BALLOON DILATION CATHETER | C.R. Bard, Inc. | 2000-01-31 | 80 | 1 |
| K990072 | BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATO | Cook Urological, Inc. | 1999-03-25 | 73 | 2 |
| K980795 | UROLOGICAL BALLOON DILATATION CATHETER | Boston Scientific Corp | 1998-04-22 | 51 | 0 |
| K970041 | ASCEND BALLOON DAILATION CATHETER | Cook Urological, Inc. | 1997-03-19 | 72 | 0 |
| K962921 | BARD A-TRAC UROLOGICAL BALLOON DILATION CATHETER | C.R. Bard, Inc. | 1996-10-09 | 75 | 0 |
| K953691 | MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING | Meadox Medicals, Div. Boston Scientific Corp. | 1995-10-16 | 69 | 0 |
| K953597 | NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATION CATHETER | Meadox Medicals, Div. Boston Scientific Corp. | 1995-10-07 | 67 | 0 |
| K953004 | DILATATION CATHETER, BALLOON | Boston Scientific Corp | 1995-09-13 | 77 | 0 |
| K945576 | MEADOX SURGIMED NOPROFILE(TM) OLBERT CATHETER SYSTEM(R) | Meadox Medicals, Div. Boston Scientific Corp. | 1995-01-24 | 71 | 0 |
| K941853 | PASSPORT | Boston Scientific Corp | 1994-09-12 | 151 | 0 |
| K942578 | ENTRAC URETERAL BALLOON DILATATION CATHETERS | American Medical Systems, Inc. | 1994-08-19 | 80 | 0 |
| K940542 | NAMIC ARIA(TM) INFLATION DEVICE | American Medical Systems, Inc. | 1994-04-18 | 70 | 0 |
| K935379 | UROLOGICAL BALLOON DILATATION CATHETER | Boston Scientific Corp | 1994-02-14 | 97 | 0 |
| K933011 | MICROVASIVE UROLOGICAL BALLOON DILATION CATHETER | Boston Scientific Corp | 1994-02-01 | 225 | 0 |
| K921839 | ENTRAC URETERAL BALLOON DILATION CATHETERS | American Medical Systems, Inc. | 1992-10-28 | 194 | 0 |
| K920946 | UROLOGICAL BALLOON DILATATION CATHETER | Boston Scientific Corp | 1992-07-01 | 121 | 0 |
| K915751 | URETEROMAT 4400 | F.M. Wiest USA, Inc. | 1992-04-24 | 123 | 0 |
| K915392 | ACCENT DG BALLOON URTERAL DILATOR SET, 10CM | Cook Urological, Inc. | 1992-03-18 | 110 | 0 |
| K914617 | CATHETER, URETERAL DILATOR | Boston Scientific Corp | 1991-12-20 | 64 | 0 |
| K912331 | URS-HYDRO-DILATOR MODEL NUMBER 2164.00 | Richard Wolf Medical Instruments Corp. | 1991-10-30 | 159 | 0 |
| K905375 | ACCENT DG BALLOON URETERAL DILATOR SET | Cook Urological, Inc. | 1991-04-12 | 133 | 0 |
| K905181 | NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY | Meadox Surgimed, Inc. | 1991-03-06 | 107 | 0 |
| K904983 | MEADOX(R) SURGIMED OLBERT CATH SYST FOR UROLOGY | Meadox Surgimed, Inc. | 1991-01-30 | 89 | 0 |
| K903813 | URETERAL BALLOON DILATATION CATHETER | Boston Scientific Corp | 1990-11-07 | 79 | 0 |
| K896448 | BALLOON DILATION CATHETER | Cook Ob/Gyn | 1990-03-07 | 118 | 0 |
| K894925 | AMCATH URETERAL DILATORS MODELS 7100,7110,7120 | Intec Medical, Inc. | 1989-12-13 | 133 | 0 |
| K884711 | URETHRAL AND URETERAL BALLOON DILATATORS | Primrose Medical, Inc. | 1989-09-29 | 325 | 0 |
| K873178 | URETERAL BULB DILATORS | Penn Medical Devices, Inc. | 1987-09-30 | 49 | 0 |
| K870697 | VAN-TEC ONE STEP URETERAL DILATATION CATHETER | Van-Tec, Inc. | 1987-03-10 | 19 | 0 |
| K852324 | URETERAL DILATOR | American Edwards Laboratories | 1985-08-21 | 83 | 0 |
| K852793 | URETERAL DILATOR/SHEATH SET | American Edwards Laboratories | 1985-08-09 | 39 | 0 |
| K851463 | OLBERT CATHETER SYS FOR URETERAL DILATION | Meadox Surgimed, Inc. | 1985-05-23 | 38 | 0 |
| K851144 | URETERAL DILATION SET | Van-Tec, Inc. | 1985-04-09 | 19 | 0 |
| K850355 | MENTOR PERCUTANEOUS RENAL DILATOR SET | Mentor Corp. | 1985-03-12 | 41 | 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