Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FGE — Predicate Candidate Screening
476 FDA 510(k) clearances under this product code; the 50 most recent screened below.
84 daysmedian FDA review time
278 days90th percentile
476clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260835 | ARCHIMEDES Biodegradable Stent (Medium) | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) | 2026-07-27 | 136 | 0 |
| K253393 | Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-52 | Hangzhou AGS MedTech Co., Ltd. | 2026-06-24 | 267 | 0 |
| K253832 | Dilation Balloon Catheter | Mirco-Tech (Nanjing) Co., Ltd. | 2026-04-24 | 144 | 0 |
| K251658 | Endoflux™ Biliary & Pancreatic Stent Sets | Medi-Globe GmbH | 2026-04-16 | 321 | 0 |
| K253987 | BARE Wireguided Balloon Dilation Catheter (1235) | GIE Medical | 2026-03-13 | 91 | 0 |
| K253132 | Single use stone retrieval balloons | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2026-03-06 | 162 | 0 |
| K251123 | Niti-S Biliary Stent; Niti-S Biliary Slim M Stent | Taewoong Medical Co., Ltd. | 2025-12-29 | 262 | 0 |
| K251019 | BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SER | Bioteque Corporation | 2025-12-22 | 264 | 0 |
| K250409 | Disposable Balloon Catheter (B5-2Q); Disposable Balloon Cath | Olympus Medical Systems Corporation | 2025-10-21 | 250 | 0 |
| K251229 | EndoFix™Tissue Fixation System | Softac Medical Technologies | 2025-08-20 | 121 | 0 |
| K243412 | ARCHIMEDES Biodegradable Pancreatic Stent | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) | 2025-07-16 | 257 | 0 |
| K251291 | Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) | Boston Scientific | 2025-07-03 | 69 | 0 |
| K242845 | EGIS Biliary Double Bare Stent (BDB080405) | S&G Biotech, Inc. | 2025-06-25 | 278 | 0 |
| K241888 | Single-use Balloon Dilatation Catheter | Leo Medical Co., Ltd. | 2024-12-20 | 175 | 0 |
| K241801 | Tornus ES | Asahi Intecc Co., Ltd. | 2024-12-17 | 179 | 0 |
| K242950 | WallFlex Biliary PLUS RX Stent System | Boston Scientific | 2024-12-06 | 74 | 0 |
| K240464 | WallFlex Biliary RX Stent System; Epic Biliary Stent System; | Boston Scientific | 2024-08-30 | 196 | 0 |
| K233079 | Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, Z | Cook Ireland, Ltd. | 2024-06-14 | 262 | 0 |
| K232245 | VedDilator ^TM (3-Stage Balloon Dilation Catheter) | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2024-02-15 | 202 | 0 |
| K232596 | EndoGI S-Path Biliary Stent System | Endogi Medical, Ltd. | 2023-09-27 | 33 | 0 |
| K223354 | EGIS Biliary Single Bare Stent | S&G Biotech, Inc. | 2023-09-21 | 323 | 0 |
| K230127 | Biliary Plastic Stent, Biliary Plastic Stent Introducer, Bil | Micro-Tech (Nanjing) Co., Ltd. | 2023-09-06 | 232 | 0 |
| K223469 | WallFlex™ Biliary RX Stent System | Boston Scientific Corporation | 2023-06-15 | 210 | 0 |
| K223626 | Niti-S Biliary Speed D Stent | Taewoong Medical Co., Ltd. | 2023-05-26 | 172 | 0 |
| K222663 | MultiStage Balloon Dilatation Catheter | Dongguan TT Medical, Inc. | 2023-03-09 | 188 | 0 |
| K223592 | Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) | Boston Scientific Corporation | 2022-12-29 | 28 | 0 |
| K222627 | EndoGI S-Path Biliary Stent System | Endo GI Medical | 2022-09-28 | 28 | 0 |
| K221071 | Niti-S Biliary Slim M Stent | Taewoong Medical Co., Ltd. | 2022-06-09 | 58 | 0 |
| K213946 | Compass BDS Biliary Stent | Cook Ireland, Ltd. | 2022-05-09 | 143 | 0 |
| K211021 | Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval | Micro-Tech (Nanjing) Co., Ltd. | 2022-05-06 | 396 | 0 |
| K210419 | BIOTEQ Drainage Catheter BT-PDS-series | Bioteque Corporation | 2022-04-13 | 426 | 0 |
| K202973 | HANAROSTENT Benefit Biliary (NNN) | M.I.Tech Co., Ltd. | 2021-05-11 | 223 | 0 |
| K203162 | Advanix Biliary Stent with NaviFlex RX Delivery System | Boston Scientific Corporation | 2020-12-18 | 56 | 0 |
| K200103 | BIOTEQ Drainage Catheter Set (One Step Type) | Bioteque Corporation | 2020-10-09 | 266 | 0 |
| K202477 | EndoGI S-Path Biliary Stent System | Endo GI Medical | 2020-09-24 | 27 | 0 |
| K193600 | EndoGI Biliary Stent System | Endogi Medical, Ltd. | 2020-06-26 | 186 | 0 |
| K181669 | ConvertX Biliary Stent System | Brightwater Medical | 2019-03-14 | 262 | 0 |
| K183396 | HANAROSTENT FASTTM Biliary (NNN) | M.I.Tech Co., Ltd. | 2019-02-11 | 66 | 0 |
| K182980 | Zilver 518 Biliary Stent, Zilver 635 Biliary Stent | Cook Ireland, Ltd. | 2018-11-16 | 18 | 0 |
| K180418 | Reliant(TM) Multistage Dilatation Balloon Catheter | Micro-Tech (Nanjing) Co., Ltd. | 2018-10-15 | 242 | 0 |
| K180868 | Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage S | Cook Ireland | 2018-07-06 | 94 | 0 |
| K173035 | Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigt | Cook Incorporated | 2018-05-01 | 215 | 3 |
| K172057 | Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stent | Cook Ireland, Ltd. | 2018-03-09 | 246 | 0 |
| K180086 | Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter | Gyrus Acmi, Inc. | 2018-03-08 | 55 | 13 |
| K172044 | Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton- | Cook Ireland, Ltd. | 2018-02-27 | 236 | 0 |
| K171548 | Cotton Graduated Dilation Catheter, Fusion Biliary Dilation | Wilson-Cook Medical, Inc. | 2017-10-13 | 140 | 0 |
| K172520 | CRE RX Biliary Balloon Dilatation Catheter | Boston Scientific Corporation | 2017-10-04 | 44 | 0 |
| K171809 | Epic Biliary Endoscopic Stent System | Boston Scientific Corporation | 2017-08-09 | 51 | 0 |
| K171623 | Nasal Pancreatic Drainage Set | Cook Ireland, Ltd. | 2017-07-31 | 59 | 0 |
| K171223 | Quantum TTC Biliary Balloon Dilator | Wilson-Cook Medical, Inc. | 2017-06-16 | 51 | 7 |
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