Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EZD — Predicate Candidate Screening
86 FDA 510(k) clearances under this product code; the 50 most recent screened below.
140 daysmedian FDA review time
300 days90th percentile
86clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260737 | Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Fe | Convatec | 2026-08-05 | 152 | 0 |
| K261658 | LoFric Origo Pro Coudé | Wellspect AB | 2026-07-17 | 59 | 0 |
| K262045 | Luja Soft | Coloplast A.S. | 2026-07-07 | 20 | 0 |
| K260394 | Hydrophilic coated intermittent nalaton catheter for single | Hangzhou Jimushi Meditech Co., Ltd. | 2026-06-24 | 138 | 0 |
| K253295 | Coude Sleeved IC; Coude Plus Sleeved IC | Hollister Incorporated | 2026-05-18 | 231 | 0 |
| K260999 | LoFric Elle Pro | Wellspect AB | 2026-04-24 | 29 | 0 |
| K252943 | GentleCath Air for Men; GentleCath Glide Intermittent Cathet | Convatec Limited | 2026-04-01 | 198 | 0 |
| K260502 | Liv Pre-lubricated Intermittent Catheter | HR Healthcare | 2026-03-12 | 27 | 0 |
| K251274 | EZ-Protect Hydrophilic Closed System Intermittent Catheter; | HR Healthcare | 2026-01-29 | 280 | 0 |
| K251178 | Ready to use Nelaton Catheter | Jamjoom Fullcare Corporation | 2026-01-02 | 261 | 0 |
| K251468 | Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sl | Hollister Incorporated | 2025-10-03 | 143 | 0 |
| K250659 | LoFric Origo | Wellspect AB | 2025-09-26 | 205 | 0 |
| K250699 | Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Cath | Convatec | 2025-07-01 | 116 | 0 |
| K251116 | Luja Coudé | Coloplast Corp. | 2025-06-27 | 77 | 0 |
| K243175 | Disposable Intermittent Catheter (TPU Catheter) | Chengdu Daxan Innovative Medical Tech. Co., Ltd. | 2025-06-26 | 269 | 0 |
| K250270 | Luja Set | Coloplast Corp. | 2025-04-17 | 77 | 0 |
| K242049 | SureCath Set | Coloplast Corp. | 2024-11-26 | 137 | 0 |
| K241210 | Luja Coude | Coloplast Corp. | 2024-11-21 | 205 | 0 |
| K241028 | Luja female (20051); Luja female (20052); Luja female (20054 | Coloplast | 2024-07-26 | 102 | 0 |
| K233524 | Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); | Hollister Incorporated | 2024-05-03 | 184 | 0 |
| K232665 | GentleCath Air for Women (CH10); GentleCath Air for Women (C | Convatec | 2024-01-25 | 147 | 0 |
| K230400 | Cure Catheter Closed System; Cure Dextra Closed System | Convatec, Inc. | 2023-11-08 | 266 | 0 |
| K233101 | Luja Coude (20108 Male CH18 - large packaging) | Coloplast Corp. | 2023-10-26 | 30 | 0 |
| K230165 | Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), | Coloplast | 2023-08-25 | 217 | 0 |
| K220722 | PVC Hydrophilic Urethral Catheter | Well Lead Medical Co., Ltd. | 2023-05-22 | 434 | 0 |
| K223756 | SimPro™ Now, GentleCath™ Hydrophilic | Dentsply Sirona | 2023-05-04 | 140 | 0 |
| K222677 | Intermittent nelaton catheter for single use | Hangzhou Jimushi Meditech Co., Ltd. | 2023-04-05 | 211 | 0 |
| K220667 | Sleeved IC | Hollister Incorporated | 2022-12-08 | 276 | 0 |
| K212567 | PVC Hydrophilic Urethral Catheter | Chengdu Daxan Innovative Medical Tech. Co., Ltd. | 2022-12-07 | 478 | 0 |
| K221401 | Self-Cath and Self-Cath Plus | Coloplast | 2022-12-02 | 200 | 0 |
| K221593 | Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus | Convatec, Inc. | 2022-11-17 | 168 | 0 |
| K222059 | SpeediCath Flex Set | Coloplast | 2022-09-21 | 70 | 0 |
| K213575 | Female IC (Not Finalized) | Hollister Incorporated | 2022-09-13 | 307 | 0 |
| K212430 | BONREE Nelaton Catheter | Bonree Medical Co., Ltd. | 2022-04-29 | 268 | 0 |
| K210250 | SpeedCath Compact Male | Coloplast | 2022-04-26 | 452 | 0 |
| K203637 | SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath | Coloplast | 2022-03-08 | 449 | 0 |
| K211212 | LoFric Elle | Dentsply Sirona | 2022-02-17 | 300 | 0 |
| K202566 | Wiygul Catheter | Big Blue Biotech, Inc. | 2020-09-30 | 26 | 0 |
| K181445 | AMSure Hydrophilic Intermittent Catheter | Amsino International, Inc. | 2018-10-01 | 122 | 0 |
| K180738 | COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneC | Compactcath, Inc. | 2018-06-14 | 84 | 0 |
| K172541 | Medline Catheter Specimen Collector | Medline Industries, Inc. | 2018-02-22 | 183 | 0 |
| K170233 | Diposable Urinary Catheter (PVC Urinary Catheter, Silicone U | Zhanjiang Star Enterprise Co., Ltd. | 2017-10-13 | 261 | 0 |
| K172247 | Magic3 Go Intermittent Urinary Catheter | C.R. Bard, Inc. | 2017-09-20 | 56 | 2 |
| K161445 | PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, P | Adapta Medical, Inc. | 2016-08-16 | 83 | 0 |
| K160858 | CompactCath Intermittent Urinary Catheter | Compactcath, Inc. | 2016-04-26 | 28 | 0 |
| K151745 | FULL CARE Disposable PVC Nelaton Catheter | Shaoxing Fuqing Health Products Co., Ltd. | 2016-03-03 | 248 | 0 |
| K150345 | Magic3 Go Intermittent Urinary Catheter | C.R. Bard, Inc. | 2015-05-11 | 89 | 2 |
| K142575 | Bard RiteCath Intermittent Urinary Catheter | C.R. Bard, Inc. | 2014-10-31 | 49 | 0 |
| K142563 | Well Lead PVC Urethral Catheter | Well Lead Medical Co., Ltd. | 2014-10-28 | 47 | 0 |
| K140945 | COMPACTCATH INTERMITTENT URINARY CATHETER | Compactcath, Inc. | 2014-08-22 | 130 | 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