Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EZL — Predicate Candidate Screening
129 FDA 510(k) clearances under this product code; the 50 most recent screened below.
117 daysmedian FDA review time
317 days90th percentile
129clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K262056 | Rusch Latex Gold Foley Catheter | Teleflex Medical Sdn. Bhd. | 2026-08-05 | 48 | 0 |
| K252537 | Rusch SoftSimplastic Foley Catheters | Teleflex Medical Sdn. Bhd. | 2026-01-20 | 161 | 0 |
| K243011 | Silicone Urethral Catheter (Silicone Urethral Catheter) | Guangdong Ecan Medical Co., Ltd. | 2025-06-16 | 263 | 0 |
| K241424 | InnoCare Specialty Foley Catheter | Innocare Urologics, LLC | 2024-09-18 | 121 | 0 |
| K232469 | Rüsch Latex Gold Foley Catheter | Teleflexmedical, Inc. | 2024-08-01 | 352 | 0 |
| K240057 | TraumaGuard Intra-abdominal Pressure Sensing System | Sentinel Medical Technologies, LLC | 2024-04-17 | 100 | 0 |
| K233411 | Folysil Silicone Catheter | Coloplast Corp. | 2024-04-15 | 192 | 1 |
| K233013 | 2-Way 100% Silicone Cleartract Catheter | Silq Technologies Corporation | 2024-01-23 | 123 | 0 |
| K212077 | Teleflex Rusch SoftSimplastic Foley Catheters | Teleflexmedical, Inc. | 2023-07-27 | 755 | 0 |
| K231101 | Flume Catheter | Flume Catheter Company, Ltd. | 2023-06-29 | 72 | 0 |
| K221020 | Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tr | Potrero Medical, Inc. | 2023-01-13 | 282 | 0 |
| K222118 | 2-Way 100% Silicone Cleartract Catheter | Silq Technologies, Corp. | 2022-12-01 | 136 | 0 |
| K221625 | 2-Way 100% Silicone ClearTract Catheter | Silq Technologies Corporation | 2022-07-01 | 25 | 0 |
| K212151 | FLUME catheter | The Flume Catheter Company, Ltd. | 2021-11-03 | 117 | 0 |
| K202134 | Well Lead All Silicone Foley Catheter with Temperature Senso | Well Lead Medical Co., Ltd. | 2021-04-08 | 251 | 0 |
| K201776 | Foley Balloon Catheter for Urology | Apollon Co., Ltd. | 2020-12-30 | 184 | 0 |
| K202698 | Prefilled Syringe | Hangzhou Primecare Medical Co., Ltd. | 2020-12-15 | 90 | 0 |
| K192034 | HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% | Pathway, LLC | 2020-04-21 | 266 | 0 |
| K200556 | AquaFlate Pre-Filled Sterile Water Syringe 10mL | H R Pharmaceuticals, Inc. | 2020-03-31 | 28 | 0 |
| K182463 | Silicone Foley Catheter | Biosensors International Pte, Ltd. | 2019-11-06 | 422 | 0 |
| K190060 | Urethrotech UCD | Urethrotech | 2019-10-04 | 266 | 0 |
| K182635 | Signal Catheter | Safe Medical Design | 2019-01-10 | 108 | 0 |
| K181616 | PSM 3-Way Silicone Foley Catheter | Pathway, LLC | 2018-09-21 | 94 | 0 |
| K180781 | Bard Vertus Foley Catheter | C.R. Bard, Inc. | 2018-09-19 | 177 | 0 |
| K181814 | AMSure Pre-filled Syringe for Balloon Inflation with Sterile | Amsino International, Inc. | 2018-09-04 | 57 | 0 |
| K173657 | Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter | Cook Incorporated | 2018-08-23 | 267 | 0 |
| K181346 | CystoSure Plus Catheter | Emmy Medical, LLC | 2018-08-06 | 77 | 0 |
| K173340 | Yikang Latex Foley Catheter | Jiangxi Yikang Medical Instrument Group Co., Ltd. | 2018-07-13 | 263 | 0 |
| K172807 | Silicone Foley Catheter for single use | Changzhou Rongxin Medicine Minimal Invasion Technology | 2018-06-04 | 259 | 0 |
| K173533 | Duette 100% Silicone Dual-Balloon, Temperature-Sensing Cathe | Poiesis Medical, LLC | 2018-03-29 | 134 | 0 |
| K172422 | Kohli Urinary Drainage Catheter | Nellie Medical, LLC | 2018-02-09 | 183 | 0 |
| K161770 | Rusch Silicone Foley Catheter | Teleflexmedical, Inc. | 2017-05-05 | 311 | 0 |
| K162989 | Rusch Simplastic Foley Catheters | Teleflexmedical, Inc. | 2017-02-24 | 120 | 0 |
| K153655 | Accuryn Monitoring System | Potrero Medical, Inc. | 2016-04-15 | 116 | 0 |
| K150550 | SilverCoat Silicone Foley Catheter | Covalontechnologies, Inc. | 2015-11-24 | 266 | 0 |
| K150699 | Bard LubriGuard Foley Catheter | C.R. Bard, Inc. | 2015-07-28 | 132 | 0 |
| K142635 | Medline Silicone Foley Catheter | Medline Industries, Inc. | 2015-01-09 | 114 | 0 |
| K140667 | WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER | Well Lead Medical Co., Ltd. | 2014-12-15 | 272 | 0 |
| K140099 | LIGHTHOUSE URINARY CATHETER | Seedings Life Science Ventures, LLC | 2014-03-04 | 47 | 0 |
| K131655 | LIGHTHOUSE(TM) URINARY CATHETER | Seedings Life Science Ventures, LLC | 2013-11-04 | 151 | 0 |
| K130908 | DISPOSABLE SILICONE FOLEY CATHETER | Guangdong Baihe Medical Technology Co., Ltd. | 2013-10-03 | 185 | 0 |
| K131020 | TEMPERATURE SENSOR CATHETER | Degania Silicone , Ltd. | 2013-05-09 | 27 | 0 |
| K110214 | DIRECTVISION CATHETER, UNCOATED | Percuvision | 2011-05-27 | 122 | 0 |
| K103371 | COUDE/ OR TIEMANN | Degania Silicone , Ltd. | 2011-03-11 | 114 | 0 |
| K101824 | AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER | Amsino International, Inc. | 2010-09-13 | 74 | 0 |
| K091516 | WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR | Well Lead Medical Co., Ltd. | 2009-10-16 | 147 | 0 |
| K091767 | 3 WAY SILICONE FOLEY BALLOON CATHETER | Cook Urological, Inc. | 2009-10-09 | 114 | 0 |
| K091699 | AMSURE HYDROPHILIC LATEX FOLEY CATHETER | Amsino International, Inc. | 2009-08-10 | 61 | 0 |
| K090262 | PERCUCATH URINARY CATHETER | Percuvision, LLC | 2009-05-28 | 114 | 0 |
| K082919 | UC-CARE POSITIONING SYSTEM | Uc-Care Medical Systems, Ltd. | 2008-10-27 | 27 | 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