Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OCX — Predicate Candidate Screening
93 FDA 510(k) clearances under this product code; the 50 most recent screened below.
88 daysmedian FDA review time
269 days90th percentile
93clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251986 | AUXILIARY WATER TUBE MAJ-855 | Olympus Medical Systems Corporation | 2025-09-26 | 91 | 0 |
| K251997 | Single-Use Biopsy Valve (MAJ-1555) | Olympus Medical Systems Corporation | 2025-09-25 | 90 | 0 |
| K242586 | ArgoCap (200.52) | Ovesco Endoscopy AG | 2025-05-22 | 265 | 0 |
| K241704 | Endoscopic Water Pump | Hangzhou AGS MedTech Co., Ltd. | 2025-03-20 | 280 | 0 |
| K242357 | Water Container (MAJ-901); Water Container (MAJ-902) | Olympus Medical Systems Corporation | 2024-10-07 | 60 | 0 |
| K241874 | Aspiration Catheter (2189) | Hobbs Medical, Inc. | 2024-09-24 | 88 | 0 |
| K242134 | ClearCap Distal Attachment | Finemedix Co., Ltd. | 2024-08-20 | 29 | 0 |
| K233442 | troCarWash™ System | Biotex, Inc. | 2024-05-21 | 216 | 0 |
| K230773 | Endoscopy Irrigation Tubing | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2023-11-21 | 245 | 0 |
| K231471 | Air/Water Bottle Tubing, CO2 Source Tubing | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2023-09-08 | 109 | 0 |
| K231418 | ENDOGATOR™ Hybrid Irrigation Tubing | Medivators | 2023-08-14 | 90 | 0 |
| K231602 | Protego Air Water Connector; Protego Air Water Bottle Tubing | Ga Health Company Limited | 2023-08-01 | 61 | 0 |
| K230932 | ANDORATE® Valve Kit | Ga Health Company Limited | 2023-07-07 | 95 | 0 |
| K222173 | Saneso Lens Wash Bottle Assembly (SAN-LWB-A) | Saneso, Inc. | 2023-02-27 | 221 | 0 |
| K222695 | troCarWash™ System | Biotex, Inc. | 2023-02-17 | 164 | 0 |
| K223171 | AquaPulse® Irrigation Tubing | Ga Health Company Limited | 2022-11-10 | 30 | 0 |
| K222734 | Diversatek Healthcare PureFlo Irrigation System / Water Bott | Diversatek Healthcare | 2022-11-08 | 60 | 0 |
| K221310 | Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tub | Changzhou Endoclean Medical Device Co., Ltd. | 2022-10-07 | 155 | 0 |
| K220785 | Clean Connecting Tube | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2022-09-27 | 194 | 0 |
| K221824 | OpClear Platform (CU3 DI3), OpClear Control Unit with Footsw | Cipher Surgical Limited | 2022-08-19 | 57 | 0 |
| K221177 | Erbe's Tubing/Cap Sets | Erbe USA, Inc. | 2022-08-11 | 108 | 1 |
| K210618 | Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation | Chongqing Jinshan Science & Technology Co., Ltd. | 2021-10-20 | 233 | 0 |
| K203350 | ENDOtube | Nissha Medical Technologies Sas | 2021-09-29 | 320 | 0 |
| K202616 | ClearCap Distal Attachment | Finemedix Co., Ltd. | 2021-02-19 | 163 | 0 |
| K202560 | AquaPulse Irrigation Tubing | Ga Health Company Limited | 2020-12-10 | 97 | 0 |
| K200479 | AquaPulse Auxiliary Water Connector | Ga Health Company Limited | 2020-05-15 | 78 | 0 |
| K200388 | Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with L | Ga Health Company Limited | 2020-04-14 | 56 | 0 |
| K193250 | Irrigation Tubing with CO2 or Air | Keymed (Medical and Industrial Equipment) , Ltd. | 2020-04-06 | 133 | 0 |
| K193036 | C2 CryoBalloon EndoGrip | Pentax Medical, A Division of Pentax of America, Inc. | 2019-11-22 | 22 | 0 |
| K191366 | Vacutore Air/Water Bottle Tubing | Smartdata Suzhou Co., Ltd. | 2019-09-06 | 107 | 0 |
| K181418 | ScopeFlow Pure(TM) | Partnership Medical Limited | 2019-07-11 | 406 | 0 |
| K181457 | EndoStream(TM) | Partnership Medical Limited | 2019-07-11 | 402 | 0 |
| K191438 | ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector | Erbe USA, Inc. | 2019-06-27 | 28 | 0 |
| K190469 | ERBEFLO 2 Disposable Tubing System | Erbe USA, Inc. | 2019-05-23 | 86 | 1 |
| K182998 | Andorate Auxiliary Water Connector | Smartdata Suzhou Co., Ltd. | 2019-04-17 | 169 | 0 |
| K182319 | Glo-Tip Spray Catheter | Wilson-Cook Medical, Inc. | 2019-02-01 | 158 | 0 |
| K182444 | ERBEFLO Olympus Scope Port Connector | Erbe USA, Inc. | 2018-11-06 | 60 | 0 |
| K182275 | Seal Single Use Biopsy Valve | Boston Scientific Corporation | 2018-09-13 | 22 | 0 |
| K181509 | Endorate Valve Sets | Smartdata Suzhou Co., Ltd. | 2018-07-06 | 28 | 0 |
| K173758 | Disposable Biopsy Valve | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2018-05-14 | 154 | 0 |
| K171637 | OpClear System | Cipher Surgical, Ltd. | 2018-02-26 | 269 | 0 |
| K161167 | Seal Single-Use Biopsy Valve | Endochoice, Inc. | 2016-05-26 | 30 | 0 |
| K152278 | ENDOFLOW II - Irrigation, Warming and Suction System | Promepla Sam | 2016-02-09 | 181 | 0 |
| K152140 | Boa Endoscopic Valve | C2 Therapeutics, Inc. | 2015-10-13 | 71 | 0 |
| K142068 | BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON;PENTAX COMPATIBLE; | Medovations, Inc. | 2015-03-10 | 223 | 0 |
| K143186 | Endo Quickconnect Olympus Scope Port Connector, Endo Quickco | Erbe USA, Inc. | 2014-12-18 | 43 | 0 |
| K140753 | ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM | Medivators | 2014-07-15 | 111 | 0 |
| K140315 | US ENDOSCOPY DISTAL ATTACHMENT CAP | United States Endoscopy Group, Inc. | 2014-04-04 | 53 | 0 |
| K133734 | SEAL SINGLE-USE BIOPSY VALVE | Endochoice, Inc. | 2014-03-19 | 100 | 0 |
| K140405 | TORRENT IRRIGATION SYSTEM | United States Endoscopy Group, Inc. | 2014-03-12 | 22 | 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