Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ODC — Predicate Candidate Screening
72 FDA 510(k) clearances under this product code; the 50 most recent screened below.
110 daysmedian FDA review time
269 days90th percentile
72clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252933 | DYNE PORT | Dyne Medical Group, Inc. | 2026-06-12 | 270 | 0 |
| K250145 | Biopsy Port Adapter | Endosound, Inc. | 2025-10-17 | 269 | 0 |
| K252910 | Orca Air/Water and Suction Valves | Boston Scientific | 2025-10-09 | 27 | 1 |
| K250949 | Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) | Olympus Medical Systems Corporation | 2025-07-16 | 110 | 2 |
| K250732 | Disposable Endoscopy Valve Set | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2025-06-20 | 101 | 0 |
| K241842 | Luer-Split MAJ-2092 | Olympus Medical Systems Corporation | 2025-03-19 | 266 | 0 |
| K250140 | Defendo Fujifilm 700 Single Use Cleaning Adapter | Steris Corparation | 2025-02-20 | 34 | 0 |
| K243075 | Defendo Single Use Cleaning Adapter for Olympus Endoscopes ( | STERIS Corporation | 2024-11-08 | 42 | 0 |
| K242742 | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS E | STERIS Corporation | 2024-10-11 | 30 | 0 |
| K241285 | Disposable Endoscope Valves Set (AF series) | Alton (Shanghai) Medical Instruments Co., Ltd. | 2024-10-01 | 147 | 0 |
| K232067 | Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo | Medivators (A Subsidiary of Steris Corporation) | 2024-03-22 | 255 | 0 |
| K232327 | Endorail | Endostart S.R.L. | 2024-03-15 | 225 | 0 |
| K232004 | Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Singl | Medivators (A Subsidiary of Steris Corporation) | 2024-03-06 | 244 | 0 |
| K240352 | Defendo Single Use Cleaning Adapter for Olympus Endoscopes | STERIS Corporation | 2024-03-06 | 30 | 0 |
| K240098 | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS E | STERIS Corporation | 2024-02-09 | 28 | 0 |
| K232329 | Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifi | Medivators (A Subsidiary of Steris Corporation) | 2023-12-21 | 140 | 0 |
| K232249 | PENTAX Medical Gas/Water Feeding Valve OE-B14 | Pentax of America, Inc. | 2023-12-01 | 126 | 0 |
| K232244 | Disposable Endoscope Valves System | Changzhou Endoclean Medical Device Co., Ltd. | 2023-11-29 | 124 | 0 |
| K222499 | Disposable Endoscope Valves Kit | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2023-11-22 | 461 | 0 |
| K232951 | BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (0 | Steris | 2023-10-20 | 29 | 0 |
| K232118 | ANDORATE® Valve Kit | Ga Health Company Limited | 2023-10-16 | 91 | 0 |
| K220884 | Disposable Endoscope Valve Sets | Sml Med-Tech Solutions Limited | 2023-01-17 | 295 | 0 |
| K222980 | Pentax Medical Valve Set | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2022-11-21 | 54 | 0 |
| K221331 | Disposable Endoscope Valves System | Changzhou Endoclean Medical Device Co., Ltd. | 2022-09-08 | 126 | 0 |
| K220210 | Disposable Endoscopy Adapter Set | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2022-06-17 | 142 | 0 |
| K221264 | FROG Forceps Valve (VAL1-F1-100) | Fujifilm Medwork GmbH | 2022-06-01 | 30 | 0 |
| K213483 | SnapLoc Wire Lock | Wilson Cook Medical | 2022-04-26 | 179 | 0 |
| K220247 | Guidewire Locking Device | Micro-Tech (Nanjing) Co., Ltd. | 2022-03-29 | 60 | 0 |
| K211814 | Wellead Endoscopic Seal | Well Lead Medical Co., Ltd. | 2022-01-14 | 217 | 0 |
| K213095 | andorate Suction Valve, andorate Air/Water Valve | Ga Health Company Limited | 2022-01-12 | 110 | 0 |
| K210625 | JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve | Fujifilm Medwork GmbH | 2021-09-10 | 192 | 0 |
| K210342 | BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extensio | STERIS Corporation | 2021-09-03 | 210 | 0 |
| K210353 | AutoCap RX | Boston Scientific Corporation | 2021-05-06 | 87 | 0 |
| K202104 | BioGuard EUS Air/Water and Suction Valves | STERIS Corporation | 2021-01-14 | 169 | 0 |
| K203630 | BioGuard Air/Water and Suction Valves | Steris Corporations | 2021-01-08 | 28 | 0 |
| K200769 | Disposable Endoscope Valves Set, Disposable Endoscope Valves | Wilson Instruments (Sha) Co., Ltd. | 2021-01-06 | 287 | 0 |
| K202237 | Locking device | Hangzhou AGS MedTech Co., Ltd. | 2020-12-23 | 138 | 0 |
| K200495 | Andorate Disposable Air/Water Valve, Andorate Disposable Suc | Ga Health Company Limited | 2020-06-24 | 117 | 0 |
| K200481 | Andorate Biopsy Valve, Andorate Biopsy Irrigator | Ga Health Company Limited | 2020-06-18 | 112 | 0 |
| K192048 | Single Use Endoscope Valves Set | Anrei Medical (Hangzhou) Co., Ltd. | 2020-05-14 | 288 | 0 |
| K192258 | Disposable Valve Sets | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2019-12-30 | 132 | 0 |
| K192059 | Bio Guard Air/Water & Suction Valves | United States Endoscopy Group, Inc. | 2019-09-17 | 47 | 0 |
| K191231 | Andorate Auxiliary Water Connector, Andorate Valves Set | Smartdata Suzhou Co., Ltd. | 2019-06-07 | 30 | 0 |
| K190164 | CleverLock Guidewire Locking Device and Biopsy Cap | Olympus Surgical Technologies America | 2019-04-04 | 63 | 0 |
| K181712 | San Antonio Stopcock | Cook Incorporated | 2018-07-26 | 28 | 0 |
| K173105 | Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-B | Cook Incorporated | 2018-03-22 | 174 | 0 |
| K162142 | Accessory Irrigation Adapter | Wilson-Cook Medical, Inc. | 2017-04-27 | 269 | 0 |
| K160403 | SmartStart Air/Water and Suction Valves | Endochoice, Inc. | 2016-05-19 | 97 | 0 |
| K151714 | Disposable Endoscope Valves Set A | Wilson Instruments (Shanghai) Company Limited | 2015-12-03 | 161 | 0 |
| K151345 | BioGuard Air/Water Valve, BioGuard Suction Valve | United States Endoscopy Group, Inc. | 2015-08-25 | 98 | 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