Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
FDS — Predicate Candidate Screening
76 FDA 510(k) clearances under this product code; the 50 most recent screened below.
133 daysmedian FDA review time
258 days90th percentile
76clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253702 | Intuitive Endoluminal Gastrointestinal System (IG1000) | Intuitive Surgical, Inc. | 2026-08-07 | 256 | 0 |
| K260573 | EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. | 2026-04-21 | 60 | 0 |
| K250550 | FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit | Fujifilm Corporation | 2026-02-17 | 357 | 0 |
| K253568 | Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114S | Fujifilm Corporation | 2026-02-06 | 81 | 0 |
| K251256 | PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family) | Pentax of America, Inc. | 2025-12-16 | 237 | 0 |
| K251041 | GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model G | Actuated Medical, Inc. | 2025-10-31 | 211 | 0 |
| K251708 | EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. | 2025-10-10 | 129 | 0 |
| K243388 | Disposable Distal Cap | Micro-Tech (Nanjing) Co., Ltd. | 2025-06-27 | 239 | 0 |
| K250900 | EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. | 2025-06-16 | 83 | 0 |
| K243512 | FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model E | Fujifilm Corporation | 2025-06-10 | 210 | 0 |
| K242635 | Endoscopic Distal Attachment (AF-D series) | Alton (Shanghai) Medical Instruments Co., Ltd. | 2025-05-30 | 269 | 0 |
| K250296 | Disposable Distal Attachment D-201 Series | Olympus Medical Systems Corp. | 2025-05-01 | 90 | 0 |
| K241213 | PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medi | Pentax of America, Inc. | 2024-12-06 | 220 | 0 |
| K242779 | Hood (DH-083ST) | Fujifilm Corporation | 2024-10-11 | 28 | 0 |
| K240142 | FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model E | Fujifilm Corporation | 2024-09-04 | 230 | 0 |
| K232997 | EVIS Exera III Gastrointestinal Videoscope GIF-1TH190 | Olympus Medical Systems Corporation | 2024-06-19 | 271 | 2 |
| K232919 | Ambu® aScope™ Gastro Large; Ambu® aBox™ 2 | Ambu A/S | 2024-04-05 | 199 | 0 |
| K232028 | Q Vision Sterile Single Use Adult Flexible Gastroscope (G-10 | Iq Endoscopes Limited | 2023-11-17 | 133 | 0 |
| K232314 | Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) | FUJIFILM Healthcare Americas Corporation | 2023-09-01 | 30 | 0 |
| K221551 | FUJIFILM Endoscope Model EI-740D/S | Fujifilm Corporaton | 2023-01-27 | 241 | 0 |
| K213606 | EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. | 2022-02-14 | 91 | 0 |
| K212382 | Ambu® aScope™ Gastro, Ambu® aBox™2 | Ambu A/S | 2022-02-03 | 185 | 0 |
| K210177 | PENTAX Medical Video Upper GI Scopes EG17-J10 | Pentax of America, Inc. | 2021-10-20 | 271 | 0 |
| K212296 | Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2 | Fujifilm Corporation | 2021-08-19 | 28 | 0 |
| K210915 | Pathfinder Endoscope Cap | Neptune Medical, Inc. | 2021-05-25 | 57 | 0 |
| K210485 | PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Med | Pentax of America, Inc. | 2021-05-13 | 83 | 0 |
| K210162 | Endoscope Model EI-740D/S | Fujifilm Corporation | 2021-04-09 | 78 | 0 |
| K192704 | Endofresh Digestive Endoscopy System | Huizhou Xzing Technology Co., Ltd. | 2020-09-02 | 341 | 0 |
| K200850 | Fujifilm Ultrasonic Processor | Fujifilm Corporation | 2020-07-06 | 97 | 0 |
| K193123 | FUJIFILM Distal Cap Models 33-40 | Fujifilm Corporation | 2019-12-11 | 29 | 0 |
| K190799 | PENTAX Medical Video Upper GI Scopes (EG Family) | Pentax of America, Inc. | 2019-11-12 | 229 | 0 |
| K183572 | FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/ | Fujifilm Corporation | 2019-07-16 | 207 | 0 |
| K182836 | FUJIFILM Endoscope Model EG-740N | Fujifilm Corporation | 2019-04-02 | 175 | 0 |
| K183686 | FUJIFILM Endoscope Model EG-530N | Fujifilm Corporation | 2019-02-28 | 62 | 0 |
| K180292 | PENTAX Video Upper G.I. Scope EG34-i10 | Pentax Medical of America, Inc. | 2018-10-12 | 253 | 0 |
| K180341 | FUJIFILM 600 Series Endoscope EG-600WR v2 | Fujifilm Corporation | 2018-08-03 | 177 | 0 |
| K181763 | FUJIFILM Ultrasonic Endoscope | Fujifilm Corporation | 2018-07-27 | 24 | 0 |
| K180911 | Visura Technologies TEECAD System | Visura Technologies, LLC | 2018-06-20 | 75 | 0 |
| K173004 | SB Soft Hood - Straight type, SB Soft Hood - Undercut type | Sumitomo Bakelite Co., Ltd. | 2018-05-08 | 223 | 0 |
| K172916 | FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and | Fujifilm Corporation | 2018-03-01 | 157 | 0 |
| K162749 | FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR | Fujifilm Medical Systems U.S.A, Inc. | 2017-06-15 | 258 | 0 |
| K153206 | Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 | Fujifilm Medical System U.S.A., Inc. | 2016-03-03 | 119 | 0 |
| K152182 | Fuse Gastroscopy System | Endochoice, Inc. | 2015-12-10 | 127 | 0 |
| K142629 | EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes | Fujifilm Medical System U.S.A., Inc. | 2015-05-14 | 240 | 0 |
| K140295 | GIS ENDOSCOPIC OPTICAL LENS | Gi Scientific, LLC | 2014-07-24 | 168 | 0 |
| K131902 | PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY) | Pentax Medical Company | 2014-04-10 | 289 | 2 |
| K131422 | PEERSCOPE SYSTEM | Endochoice, Inc. | 2013-10-10 | 147 | 0 |
| K130148 | FOREIGN BODY HOOD | United States Endoscopy Group, Inc. | 2013-08-07 | 197 | 0 |
| K123317 | EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N | Olympus Medical Systems Corporation | 2012-12-11 | 47 | 0 |
| K120446 | FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT | Fujinon, Inc. | 2012-08-13 | 181 | 1 |
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