Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
FET — Predicate Candidate Screening
100 FDA 510(k) clearances under this product code; the 50 most recent screened below.
84 daysmedian FDA review time
244 days90th percentile
100clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261880 | FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscop | Fujifilm Corporation | 2026-07-02 | 27 | 0 |
| K261260 | HD Camera Head OLYMPUS CH-S200-08-LB | Olympus Medical Systems Corporation | 2026-06-24 | 69 | 0 |
| K251734 | ProVee Video Processing Unit (PV-003) | Proverum Limited | 2025-09-24 | 110 | 0 |
| K250462 | UL UHD-Clear View 4K Camera System (UL-3Chip 4K) | Univlabs Technologies Private Limited | 2025-08-11 | 174 | 0 |
| K250204 | Endoscopic Camera System | Shenzhen Sophway Technology Co., Ltd. | 2025-07-01 | 158 | 0 |
| K243260 | FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R | Fujifilm Corporation | 2025-04-11 | 178 | 0 |
| K242067 | VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISER | Olympus Corporations of the Americas | 2025-04-02 | 261 | 0 |
| K243321 | Endoscopic Video Image Processor (RP-IPD-V1000F) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2025-02-07 | 107 | 0 |
| K241532 | Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2024-10-22 | 145 | 0 |
| K241371 | VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S | Olympus Medical Systems Corporation | 2024-07-03 | 49 | 0 |
| K222584 | EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOP | Olympus Medical Systems Corporation | 2023-04-26 | 243 | 1 |
| K212808 | Logic Hd camera head green, System green | Richard Wolf Medical Instruments Corporation | 2022-06-14 | 284 | 0 |
| K221174 | Telepack + | Karl Storz Endoscopy America, Inc. | 2022-05-13 | 18 | 0 |
| K211332 | D Camera Controller | Richard Wolf Medical Instruments Corporation | 2021-10-01 | 151 | 0 |
| K202646 | Visera Elite II Video System Center | Olympus Medical Systems Corp. | 2020-10-29 | 48 | 0 |
| K201135 | Image1 S CCU, Image1 S 4U Camera Head | KARL STORZ Endoscopy-America, Inc. | 2020-09-01 | 126 | 0 |
| K201200 | Visera Elite II Video System Center | Olympus Medical Systems Corp. | 2020-07-22 | 79 | 0 |
| K200617 | Logic HD Camera Controller, Logic HD Lite Camera Controller, | Richard Wolf Medical Instruments Corporation | 2020-06-23 | 106 | 0 |
| K192286 | FUJIFILM EP-6000 Video Processor | Fujifilm Corporation | 2020-05-01 | 253 | 0 |
| K193235 | Telepack + | Karl Storz Endoscopy America, Inc. | 2019-12-20 | 25 | 0 |
| K190449 | Visera Elite II Video System Center, Visera Elite II HD 3CMO | Olympus Medical Systems Corp. | 2019-08-30 | 186 | 0 |
| K190648 | Pusen Eview Medical Video Endoscope Image Processor | Zhuhai Pusen Medical Technology Co., Ltd. | 2019-03-29 | 16 | 0 |
| K182696 | Telepack X LED | KARL STORZ Endoscopy-America, Inc. | 2018-11-20 | 54 | 0 |
| K180583 | LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD | Richard Wolf Medical Instruments Corporation | 2018-06-28 | 115 | 0 |
| K180414 | EPX-4440FN Digital Video Processor with Light Source | Fujifilm New Development U.S.A., Inc. | 2018-05-24 | 98 | 0 |
| K172817 | 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA | Olympus Medical Systems Corp. | 2017-10-17 | 29 | 0 |
| K163675 | Processor VP-7000, Light Source BL-7000 | Fujifilm Medical System U.S.A., Inc. | 2017-04-25 | 119 | 0 |
| K161204 | ENDOCAM Flex HD Camera System 5521 | Richard Wolf Medical Instruments Corporation | 2017-01-11 | 258 | 0 |
| K160044 | Image1 SPIES System | Karl Storz Endoscopy America, Inc. | 2016-02-01 | 24 | 0 |
| K152109 | HD-Camera HDC1000 | W.O.M. World of Medicine GmbH | 2015-10-13 | 76 | 0 |
| K150221 | EPX-4440HD and EPX-4400HD with FICE | Fujifilm Medical System U.S.A., Inc. | 2015-10-01 | 244 | 0 |
| K131953 | IMAGE1 SPIES | KARL STORZ Endoscopy-America, Inc. | 2013-12-20 | 176 | 1 |
| K130423 | THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525 | Richard Wolf Medical Instruments Corp. | 2013-04-03 | 42 | 0 |
| K113873 | PENTAX EPK-I5020 VIDEO PROCESSOR | Pentax of America, Inc. | 2012-06-22 | 175 | 0 |
| K111997 | IMAGE1 GI CCU MODEL 22203020-114 | KARL STORZ Endoscopy-America, Inc. | 2012-04-06 | 268 | 0 |
| K102949 | COLONOSCOPY ASSISTANT | Sti Medical Systems, LLC | 2011-06-15 | 253 | 0 |
| K102466 | FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR | Fujinon, Inc. | 2011-05-25 | 268 | 0 |
| K102059 | AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017 | Olympus Medical Systems Corporation | 2010-10-08 | 78 | 0 |
| K090800 | VS-100 ILLUMINATION AND IMAGING SYSTEM | Schoelly Imaging, Inc. | 2009-05-18 | 55 | 0 |
| K083155 | HD CAMERA HEAD OTV-S7PROH-HD-L08E | Olympus Medical Systems Corporation | 2009-01-13 | 81 | 0 |
| K080809 | IEC MEDSIGHT AND MEDBRIGHT | Innovative Endoscopy Components, LLC | 2008-08-11 | 143 | 0 |
| K081585 | ENDOSCOPY VIDEO CAMERA SYSTEM | Vision Systems Group, A Division of Viking Systems | 2008-06-20 | 15 | 0 |
| K070716 | IMAGE 1 VIDEO IMAGING SYSTEM WITH OPTIONAL INSUFFLATORS CONT | KARL STORZ Endoscopy-America, Inc. | 2007-05-31 | 78 | 0 |
| K043324 | AIDA WITH DICOM AND HL7 INTERFACE | KARL STORZ Endoscopy-America, Inc. | 2005-04-04 | 123 | 0 |
| K041494 | OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNI | Olympus Corporation | 2004-07-01 | 27 | 0 |
| K031895 | KSEA OPSERVER LAP | KARL STORZ Endoscopy-America, Inc. | 2003-09-23 | 96 | 0 |
| K032544 | VP-1000; MED CAM 100; VP-3000A; MED CAM 300 | Mgb Endoskopische Gerate GmbH (Berlin) | 2003-09-02 | 15 | 0 |
| K032545 | ENDOSCOPIC LIGHT SOURCE LS-3000X; LS-1800XG/MED LIGHT X 180; | Mgb Endoskopische Gerate GmbH (Berlin) | 2003-09-02 | 15 | 0 |
| K023659 | 1-CCD ENDOCAM 5520 SYSTEM | Richard Wolf Medical Instruments Corp. | 2003-01-29 | 90 | 0 |
| K020301 | MODIFICATION TO VISTA STEREOSCOPE SYSTEM | Vista Medical Technologies, Inc. | 2002-02-12 | 14 | 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