Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FAD · Predicate Candidate Screening
122 FDA 510(k) clearances under this product code; the 50 most recent screened below.
107 daysmedian FDA review time
282 days90th percentile
122clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251890 | Disposable Ureteral Stents | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2026-02-20 | 245 | 0 |
| K251469 | Endura™ Ureteral Stent and Stent Set | Cathegenix (Xiamen) Co., Ltd. | 2025-12-19 | 220 | 0 |
| K243039 | Ureteral Stents (AF-D series) | Alton (Shanghai) Medical Instruments Co., Ltd. | 2025-06-18 | 264 | 0 |
| K243830 | Disposable ureteral stent | Shenzhen Trious Medical Technology Co., Ltd. | 2025-05-14 | 152 | 0 |
| K250824 | Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Per | Boston Scientific Corporation | 2025-04-15 | 28 | 0 |
| K232920 | RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, REL | Ureteral Stent Company | 2024-03-22 | 185 | 0 |
| K211934 | APDL Drainage Catheter System, Flexima APDL Drainage Cathete | Boston Scientific Corporation | 2022-11-10 | 506 | 5 |
| K213185 | ImaJin Silicone double loop ureteral stent kits, ImaJin Pyel | Coloplast Corp. | 2022-06-08 | 252 | 0 |
| K213444 | RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELI | Ureteral Stent Company | 2022-03-17 | 143 | 0 |
| K213186 | NovoFlow Reinforced Ureteral Stent | Coloplast Corp. | 2022-02-16 | 140 | 0 |
| K212868 | JFil Ureteral Stents, JFil Ureteral Stents ECO KIT | Rocamed Sam | 2022-01-26 | 139 | 0 |
| K200260 | Percuflex Ureteral Stent System, Percuflex Ureteral Stent Sy | Boston Scientific Corporation | 2021-04-26 | 448 | 0 |
| K201436 | Vortek Single Loop Ureteral Stent | Coloplast Corp. | 2021-02-25 | 269 | 0 |
| K191446 | Ureteral Stent Systems, Biliary Drainage Catheters | Boston Scientific Corporation | 2020-01-02 | 216 | 0 |
| K190659 | Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Urete | Allwin Medical Devices, Inc. | 2019-12-02 | 263 | 0 |
| K190312 | Dornier Ureteral Stent | Dornier Medtech America, Inc. | 2019-11-15 | 276 | 0 |
| K191609 | Tria Soft Ureteral Stent | Boston Scientific Corporation | 2019-08-16 | 60 | 0 |
| K190603 | Tria Firm Ureteral Stent | Boston Scientific Corporation | 2019-05-24 | 77 | 0 |
| K181971 | Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy St | Cook Incorporated | 2019-04-23 | 273 | 0 |
| K180557 | Greene Renal Transplant Stent Set | Cook Incorporated | 2018-11-23 | 267 | 0 |
| K180469 | ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent | Coloplast Corp. | 2018-11-06 | 258 | 0 |
| K180216 | Seidmon Antegrade AQ Stent Set | Cook Incorporated | 2018-09-28 | 246 | 0 |
| K180029 | Malecot Nephrostomy Catheter/Stent Set | Cook Incorporated | 2018-09-21 | 261 | 0 |
| K180053 | Sof-Flex Ureteral Stent Set | Cook Incorporated | 2018-09-13 | 248 | 0 |
| K171603 | Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set | Cook Incorporated | 2018-04-16 | 319 | 0 |
| K172017 | Black Silicone Filiform Double Pigtail Stent Set | Cook Incorporated | 2018-03-26 | 266 | 0 |
| K173734 | RocaJJ Soft Stents | Promepla Sam | 2018-03-12 | 96 | 0 |
| K180057 | VORTEK URETERAL DOUBLE LOOP STENT | Coloplast Corp. | 2018-03-09 | 60 | 0 |
| K170362 | VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS | Coloplast Corp. | 2017-11-15 | 282 | 0 |
| K170422 | BIOSOFT DUO DOUBLE LOOP URETERAL STENTS | Coloplast Corp. | 2017-11-02 | 262 | 0 |
| K172289 | pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent | Q Urological Corporation | 2017-10-04 | 65 | 0 |
| K170010 | Salle Intraoperative Pyeloplasty Stent Set | Cook Incorporated | 2017-08-28 | 237 | 0 |
| K163399 | Tria Firm Ureteral Stent | Boston Scientific Corporation | 2017-06-22 | 199 | 0 |
| K162109 | Kwart Retro-Inject Ureteral Stent | Cook Incorporated | 2017-06-07 | 313 | 0 |
| K162104 | C-Flex Ureteral Stent Set | Cook Incorporated | 2017-04-24 | 269 | 0 |
| K161236 | Universa Firm Ureteral Stents and Stent Sets | Cook Incorporated | 2017-01-27 | 270 | 0 |
| K163068 | pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent | Q Urological Corporation | 2016-12-22 | 50 | 0 |
| K161277 | ConvertX Nephroureteral Stent System | Brightwater Medical | 2016-11-22 | 200 | 0 |
| K160891 | Ultrathane Endoureterotomy Stent Set | Cook Incorporated | 2016-06-24 | 85 | 0 |
| K151051 | Universa Soft Ureteral Stents and Stent Sets | Cook Incorporated | 2016-01-11 | 266 | 0 |
| K141344 | EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTE | Boston Scientific Corp | 2014-10-17 | 148 | 0 |
| K082805 | PAGUAMEDICINA STRUCTURAL HYDROGEL PEDIATRIC URETERAL STENT, | Q Urological Corporation | 2010-01-20 | 483 | 0 |
| K072293 | FOSSA URETERAL OPEN STENTS | Fossa Medical, Inc. | 2008-08-06 | 356 | 0 |
| K063742 | RESONANCE METALLIC URETERAL STENT | Cook Ireland, Ltd. | 2007-05-08 | 141 | 0 |
| K060673 | PEDIATRIC URETERAL STENT | Applied Medical Resources Corp. | 2006-03-29 | 15 | 6 |
| K033210 | BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET | Bioteque Corp. | 2004-12-30 | 454 | 0 |
| K043193 | BARD INLAYOPTIMA URETERAL STENT WITH SUTURE | C.R. Bard, Inc. | 2004-12-07 | 19 | 4 |
| K040760 | MODIFICATION TO URETERAL STENT | Applied Medical Resources Corp. | 2004-10-15 | 204 | 6 |
| K031292 | MODIFICATION TO FOSSA URETERAL STONE SWEEPER | Fossa Medical, Inc. | 2003-05-22 | 29 | 0 |
| K030503 | MODIFICATION TO CONTOUR POLARIS URETERAL STENT | Boston Scientific Corp | 2003-03-17 | 26 | 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