Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KOD — Predicate Candidate Screening
238 FDA 510(k) clearances under this product code; the 50 most recent screened below.
65 daysmedian FDA review time
213 days90th percentile
238clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251864 | Rubber Utility Catheter | C.R. Bard, Inc. | 2026-02-23 | 251 | 0 |
| K220036 | Wellead Ureteral Catheter | Well Lead Medical Co., Ltd. | 2022-12-16 | 345 | 0 |
| K220730 | allFlex Ureteral Catheters, Krait Ureteral Catheters | Allwin Medical Devices, Inc. | 2022-10-13 | 213 | 0 |
| K211032 | Urinary Catheter 12 Fr, Urinary Catheter 16 Fr | Urogen Pharma, Ltd. | 2021-11-19 | 226 | 0 |
| K181979 | Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Ca | Teleflexmedical, Inc. | 2019-05-24 | 303 | 0 |
| K180354 | UroGen Ureteral Catheter | Urogen Pharma, Ltd. | 2018-10-30 | 264 | 0 |
| K181144 | Angled Tip Ureteral Catheter | Cook Incorporated | 2018-06-28 | 58 | 0 |
| K180530 | Imager II Urology Torque Catheter | Boston Scientific Corporation | 2018-04-10 | 41 | 0 |
| K171810 | Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter | Cook Incorporated | 2018-03-07 | 261 | 0 |
| K171600 | Renal Access Cobra Catheter, Kumpe Access Catheter | Cook Incorporated | 2018-02-16 | 260 | 0 |
| K171662 | Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-F | Cook Incorporated | 2018-02-01 | 241 | 0 |
| K172924 | GentleCath Intermittent Urinary Catheter | Convatec Limited | 2017-11-21 | 57 | 0 |
| K161344 | GentleCath Glide Intermittent Catheter | Convatec Limited | 2016-09-20 | 130 | 0 |
| K160877 | United Urologics Closed System Catheter | Robling Medical, Inc. | 2016-05-20 | 51 | 0 |
| K140953 | GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETE | Convatec, Ltd. | 2014-08-01 | 109 | 0 |
| K110491 | BACKSTOP CATHETER | Pluromed, Inc. | 2011-03-16 | 22 | 0 |
| K103349 | BACKSTOP CATHETER | Pluromed, Inc. | 2011-01-07 | 52 | 0 |
| K102527 | IMAGER II UROLOGY TORQUE CATHETER (C1 TIP); IMAGER II UROLOG | Boston Scientific Corporation | 2010-11-05 | 64 | 1 |
| K090270 | BACKSTOP CATHETER, MODEL 60-0000-3100 | Pluromed, Inc. | 2009-05-15 | 100 | 0 |
| K080878 | MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH | Medical Technologies of Georgia, Inc. | 2008-07-17 | 108 | 0 |
| K080881 | CURE CATHETER CLOSED SYSTEM | Cure Medical, LLC | 2008-06-11 | 72 | 0 |
| K040897 | DOVER ROB-NEL CATHETER | Tyco Healthcare | 2004-07-20 | 105 | 0 |
| K041243 | DOVER RED RUBBER ROBINSON CATHETER | Tyco Healthcare | 2004-07-07 | 57 | 0 |
| K033719 | BARD TIGERTAIL URETERAL CATHETER | C.R. Bard, Inc. | 2004-02-04 | 70 | 0 |
| K032710 | CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT | Apogee Medical, Inc. | 2004-01-09 | 129 | 0 |
| K033023 | INTERMITTENT URETHRAL CATHETERS | Rusch Intl. | 2003-12-23 | 88 | 0 |
| K022135 | URETERAL ACCESS SHEATH SET (UASS) | Boston Scientific Corp | 2002-09-13 | 74 | 0 |
| K013483 | INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CAT | Hollister, Inc. | 2002-01-14 | 87 | 0 |
| K013345 | INCARE INTERMITTENT CATHETER | Hollister, Inc. | 2002-01-07 | 90 | 0 |
| K011965 | IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, A | Boston Scientific Corp | 2001-07-13 | 18 | 2 |
| K010339 | ENDOCARE PERCUTANEOUS ACCESS SET | Endocare, Inc. | 2001-03-07 | 30 | 0 |
| K002396 | ENDOCARE PERCUTANEOUS ACCESS SET | Endocare, Inc. | 2000-10-13 | 67 | 0 |
| K001583 | ISLAND BIOSURGICAL BNS KIT #3 | Island Biosurgical, LLC | 2000-07-13 | 52 | 0 |
| K000723 | HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (H | Rochester Medical Corp. | 2000-05-19 | 74 | 23 |
| K000070 | FLOCATH | Rusch Intl. | 2000-02-18 | 39 | 1 |
| K965229 | IMAGER TORQUE CATHETER | Boston Scientific Corp | 1997-03-04 | 63 | 0 |
| K951260 | URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBR | Biosearch Medical Products, Inc. | 1995-09-27 | 190 | 0 |
| K945061 | NOPROFILE OLBERT CATHETER SYSTEM | Meadox Surgimed, Inc. | 1995-03-09 | 146 | 0 |
| K922527 | BARD URODYNAMIC CATHETERIZATION PROCEDURE TRAY | C.R. Bard, Inc. | 1994-04-14 | 686 | 0 |
| K933109 | 4SURE URO-LINK UROLOGICAL PROCEDURE TRAYS | Boston Pacific Medical, Inc. | 1994-03-28 | 276 | 0 |
| K915459 | FLOWMATE HAND PUMP | Psi Medical Products, Inc. | 1994-02-15 | 804 | 0 |
| K931195 | PERCUTANEOUS DRAINAGE LOOP CATHETER SET | Cook Urological, Inc. | 1993-12-22 | 288 | 0 |
| K933400 | KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMPERATURE SE | Kendall Healthcare Products Co. Div.Of Tyco Health | 1993-11-15 | 126 | 0 |
| K930608 | ONIK-COHEN ACCESS SET | Cook Urological, Inc. | 1993-07-09 | 154 | 0 |
| K923906 | FOLEY INSERTION TRAY | Kit Pak, Inc. | 1993-06-22 | 322 | 0 |
| K922051 | KIT PAK'S FLUSHING KIT | Kit Pak, Inc. | 1993-06-17 | 412 | 0 |
| K922431 | BARD LATEX URINARY CATHETERS | C.R. Bard, Inc. | 1993-03-25 | 307 | 0 |
| K923607 | RADIFOCUS GUIDE WIRE M | Terumo Medical Corp. | 1992-10-02 | 78 | 0 |
| K921054 | KENDALL MOD. PEDIATRIC ULTRAMER POLYURETHANE CATH. | Kendall Healthcare Products Co. Div.Of Tyco Health | 1992-09-23 | 202 | 0 |
| K921415 | IRRIGATION TUBING SET | Psi Medical Products, Inc. | 1992-09-04 | 164 | 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