Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KNS · Predicate Candidate Screening
188 FDA 510(k) clearances under this product code; the 50 most recent screened below.
78 daysmedian FDA review time
259 days90th percentile
188clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260962 | Sphincterotome | Taewoong Medical Co., Ltd. | 2026-05-21 | 59 | 0 |
| K252388 | Vanquish Water Vapor Ablation Device | Francis Medical, Inc. | 2025-11-26 | 118 | 0 |
| K252889 | Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) | Olympus Medical Systems Corporation | 2025-11-25 | 76 | 0 |
| K250945 | Single Use Preloaded Sphincterotome V (Distal Wire Guided) ( | Olympus Medical Systems Corp. | 2025-10-17 | 203 | 16 |
| K250351 | Single Use Electrosurgical Knife (KD-612L, KD-612U); Single | Olympus Medical Systems Corporation | 2025-10-10 | 245 | 0 |
| K251104 | SureTome™ SW Sphincterotome with DomeTip | Wilson-Cook Medical | 2025-09-29 | 171 | 0 |
| K251226 | Aqua Medical RF Vapor Ablation System | Aqua Medical, Inc. | 2025-08-08 | 109 | 0 |
| K250584 | Rezum System | Boston Scientific Corporation | 2025-06-11 | 104 | 0 |
| K242774 | SpydrBlade Flex Instrument (PRD-RG1-001) | Creo Medical, Ltd. | 2025-06-06 | 266 | 0 |
| K241855 | SB Knife Jr2 (MD-47702 and MD-47702L) | Sb-Kawasumi Laboratories, Inc. | 2025-03-26 | 272 | 0 |
| K242192 | Disposable Sphincterotome | Beijing Zksk Technology Co., Ltd. | 2025-02-06 | 195 | 0 |
| K243568 | Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord | Wilson-Cook Medical, Inc. | 2025-01-17 | 60 | 1 |
| K241271 | Aqua Medical RF Vapor Ablation System | Aqua Medical, Inc. | 2024-12-12 | 220 | 0 |
| K242061 | Reusable Interface Cable 1.5 m (PRD-IFC-002) | Creo Medical, Ltd. | 2024-08-15 | 31 | 0 |
| K232825 | Disposable Sphincterotome | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2024-03-29 | 198 | 0 |
| K232633 | Gold Probe Bipolar Electrohemostasis Catheter; Injection Gol | Boston Scientific | 2023-11-28 | 90 | 0 |
| K232476 | Disposable Sphincterotome | Zhejiang Soudon Medical Technology Co., Ltd. | 2023-11-07 | 83 | 0 |
| K230328 | Speedboat Flush SB1 Instrument | Creo Medical, Ltd. | 2023-10-31 | 267 | 0 |
| K233318 | AXIOS Stent and Electrocautery-Enhanced Delivery System (6mm | Boston Scientific Corporation | 2023-10-27 | 28 | 18 |
| K233113 | ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, | Starmed Co., Ltd. | 2023-10-25 | 28 | 0 |
| K232162 | Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphinc | Boston Scientific Corporation | 2023-08-14 | 24 | 0 |
| K231533 | Habib EndoHPB | Boston Scientific Corporation | 2023-06-21 | 26 | 0 |
| K222421 | Sphincterotome | Hangzhou AGS MedTech Co., Ltd. | 2023-05-03 | 265 | 0 |
| K223256 | Optimos™ Cystotome | Taewoong Medical Co., Ltd. | 2023-04-05 | 166 | 0 |
| K222542 | MCB UNIT Model: V10GMCBUS | Lamidey Noury Medical | 2022-09-21 | 30 | 0 |
| K211909 | Cysto-Gastro-Sets | G-Flex Europe Sprl | 2022-06-09 | 353 | 0 |
| K212999 | Multi-Functional Electrosurgical Knife | Anrei Medical (Hangzhou) Co., Ltd. | 2022-03-21 | 182 | 0 |
| K213627 | RF Vapor System | Aqua Medical, Inc. | 2021-12-17 | 30 | 0 |
| K210934 | Sphincterotome / short-wire compatible, Sterile Sphincteroto | Micro-Tech (Nanjing) Co., Ltd. | 2021-12-01 | 247 | 0 |
| K211282 | Aqua Medical RF Vapor System | Aqua Medical, Inc. | 2021-05-27 | 30 | 0 |
| K201121 | Sphincterotome | Hangzhou AGS MedTech Co., Ltd. | 2021-02-05 | 284 | 0 |
| K200404 | ORISE ProKnife | Boston Scientific Corporation | 2020-12-03 | 288 | 0 |
| K192342 | Electrosurgical System (Electrosurgical Generator with Bipol | Hangzhou AGS MedTech Co., Ltd. | 2020-05-21 | 267 | 0 |
| K192905 | Creo Electrosurgical System with HS1 Hemostasis Accessory | Creo Medical, Ltd. | 2020-03-19 | 156 | 0 |
| K192339 | TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord | Wilson-Cook Medical, Inc. | 2020-01-30 | 155 | 0 |
| K193039 | Single Use Balloon Dilator V (with knife) | Olympus Medical Systems Corp. | 2019-12-17 | 47 | 0 |
| K191505 | Rezum System | Nxthera (A Boston Scientific Company) | 2019-08-02 | 57 | 0 |
| K183595 | Aqua Medical RF Vapor System | Aqua Medical, Inc. | 2019-06-21 | 182 | 0 |
| K182408 | Single Use Electrosurgical Knife KD-625 , Single Use Electro | Olympus Medical Systems Corp. | 2019-05-15 | 253 | 3 |
| K190621 | SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr typ | Sumitomo Bakelite Co., Ltd. | 2019-04-23 | 43 | 0 |
| K181758 | ELRA Electrode | Starmed Co., Ltd. | 2019-04-11 | 283 | 0 |
| K190093 | Rezum Delivery Device, Rezum Generator | Nxthera (A Boston Scientific Company) | 2019-03-25 | 66 | 0 |
| K172665 | Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sp | Wilson-Cook Medical Inc./Cook Endoscopy | 2018-05-24 | 261 | 0 |
| K172288 | Fusion OMNI Sphincterotome | Wilson-Cook Medical Inc./Cook Endoscopy | 2018-04-17 | 260 | 0 |
| K180165 | Habib EndoHPB | Emcision , Ltd. | 2018-03-20 | 57 | 0 |
| K180237 | Rezum System | Nxthera, Inc. | 2018-02-27 | 29 | 0 |
| K173559 | Barrx SB RFA Endoscopic Catheter | Covidien, LLC | 2018-01-18 | 62 | 0 |
| K171158 | Single Use Electrosurgical knife | Olympus Medical Systems Corp. | 2017-11-17 | 211 | 0 |
| K171993 | Zimmon Needle Knife Papillotome | Wilson-Cook Medical Inc./Cook Endoscopy | 2017-08-17 | 45 | 0 |
| K171983 | Creo Medical Electrosurgical System including Speedboat RS2 | Creo Medical, Ltd. | 2017-08-17 | 48 | 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