Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GBM — Predicate Candidate Screening
71 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
261 days90th percentile
71clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241734 | Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wel | Well Lead Medical Co., Ltd. | 2025-03-05 | 261 | 0 |
| K213283 | GentleCath Air for Men Hydrophilic Intermittent Urinary Cath | Convatec Limited | 2022-06-22 | 264 | 0 |
| K211436 | Intermittent Catheter (Not Finalized) | Hollister Incorporated | 2022-01-27 | 262 | 0 |
| K200820 | SpeediCath Compact Set | Coloplast | 2020-11-13 | 228 | 0 |
| K192904 | SpeediCath Compact Set | Coloplast | 2020-11-02 | 384 | 0 |
| K200142 | SpeediCath Soft | Coloplast | 2020-07-30 | 190 | 0 |
| K200134 | Jimushi Sterile Urethral Catheter for single use | Hangzhou Jimushi Meditech Co., Ltd. | 2020-06-01 | 132 | 0 |
| K191512 | LotusCatheter (Lotus No Balloon Catheter) | Hakki Medical Technologies, Inc. | 2020-05-21 | 349 | 0 |
| K192577 | Actreen Hi-Lite Intermittent Urinary Catheters | B.Braun Medical, Inc. | 2020-05-07 | 231 | 0 |
| K193148 | VaPro Plus Pocket, VaPro Plus | Hollister Incorporated | 2019-12-13 | 30 | 0 |
| K192468 | Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, | Hangzhou Bever Medical Devices Co., Ltd. | 2019-11-27 | 79 | 1 |
| K191633 | Infyna Chic | Hollister Incorporated | 2019-07-19 | 30 | 0 |
| K190620 | SpeediCath Flex Coude Pro | Coloplast | 2019-07-10 | 121 | 0 |
| K183335 | Medline Poly-Cath Red Polymer Urethral Catheter | Medline Industries, Inc. | 2019-06-12 | 191 | 0 |
| K183461 | Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG H | Teleflexmedical, Inc. | 2019-05-08 | 145 | 0 |
| K182511 | SimplCath | F&S Medical Solutions, LLC | 2019-03-20 | 189 | 0 |
| K183253 | ValPro 2 Plus, VaPro 2 Plus Pocket | Hollister Incorporated | 2018-12-18 | 27 | 0 |
| K180801 | Actreen Hi-Lite Cath, Actreen Hi-Lite Set | B.Braun Medical, Inc. | 2018-11-05 | 222 | 0 |
| K180258 | SpeediCath Standard | Coloplast | 2018-10-25 | 268 | 0 |
| K181206 | GentleCath Glide Intermittent Urinary Catheter | Convatec Limited | 2018-08-16 | 101 | 0 |
| K180824 | VaPro 2 Intermittent Catheter | Hollister Incorporated | 2018-06-22 | 84 | 0 |
| K180070 | SpeediCath Flex Coude Pro | Coloplast | 2018-02-02 | 24 | 0 |
| K172278 | Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Uret | Cook Incorporated | 2017-11-22 | 117 | 0 |
| K163179 | Onli Intermittent Catheter | Hollister Incorporated | 2017-01-26 | 73 | 0 |
| K161672 | SpeediCath Flex Coude | Coloplast Corp. | 2016-09-29 | 112 | 0 |
| K160795 | United Urologics Intermittent Catheter | Robling Medical | 2016-06-16 | 85 | 0 |
| K151772 | Actreen Mini Intermittent Urinary Catheters | B.Braun Medical, Inc. | 2016-02-09 | 224 | 0 |
| K152268 | VAPRO PLUS POCKET Intermittent Catheter | Hollister Incorporated | 2015-09-09 | 29 | 0 |
| K150935 | SpeediCath Compact Eve | Coloplast A/S | 2015-07-02 | 86 | 0 |
| K142767 | ThinkMed Intermittent Catheter with/without Hydrophilic Coat | Thinkmed Medical Technology Co., Ltd. | 2015-02-03 | 131 | 0 |
| K143182 | Speedicath Compact Male | Coloplast A/S | 2015-01-20 | 76 | 0 |
| K143594 | VaPro Pocket | Hollister Incorporated | 2015-01-09 | 22 | 0 |
| K141642 | VAPRO INTERMITTENT CATHETER | Hollister Incorporated | 2014-08-22 | 64 | 0 |
| K121457 | SPEEDICATH COMPACT SET (12 FR) | Coloplast Corp. | 2012-10-02 | 139 | 0 |
| K121458 | SPEEDICATH COMPACT SET (12/18 FR) | Coloplast A/S | 2012-10-01 | 138 | 0 |
| K111405 | BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON- | Hangzhou Bever Medical Devices Co., Ltd. | 2012-02-13 | 270 | 0 |
| K110862 | VAPRO PLUS INTERMITTENT CATHETER | Hollister Incorporated | 2011-04-26 | 28 | 0 |
| K101900 | HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FREN | Hakki Medical Technologies, Inc. | 2011-02-07 | 215 | 0 |
| K090960 | VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122 | Hollister, Inc. | 2009-08-20 | 136 | 0 |
| K072808 | SPEEDICATH COMPACT | Coloplast Corp. | 2007-11-09 | 39 | 0 |
| K063795 | GUARDIANCATHETER-URINARY DRAINAGE CATHETER | Marian Medical, Inc. | 2007-03-05 | 73 | 0 |
| K060268 | PEDIATRIC URINARY CATHETER | Clay Kennard | 2006-02-24 | 23 | 0 |
| K050874 | ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER | Astra Tech, Inc. | 2005-05-05 | 29 | 0 |
| K043241 | LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER | Astra Tech, Inc. | 2004-12-23 | 30 | 0 |
| K031409 | URINARY CATHETERS | Promedic, Inc. | 2003-06-17 | 43 | 0 |
| K021938 | VITALCARE URETHRAL CATHETER | Vitalcare, Inc. | 2003-04-22 | 314 | 0 |
| K023254 | SPEEDICATH | Coloplast Corp. | 2003-01-27 | 119 | 0 |
| K020714 | RUSCH FLONEIL; FLOCATH INTROGEL | Rusch Intl. | 2002-07-01 | 118 | 0 |
| K012374 | MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER | Astra Tech, Inc. | 2001-08-23 | 28 | 0 |
| K011552 | UROLOGICAL CATHETER | Apogee Medical, Inc. | 2001-07-18 | 61 | 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