Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FDT — Predicate Candidate Screening
35 FDA 510(k) clearances under this product code; the 50 most recent screened below.
88 daysmedian FDA review time
272 days90th percentile
35clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251861 | FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model | Fujifilm Corporation | 2026-03-09 | 265 | 0 |
| K253646 | Single Use Distal Cover MAJ-2315 (MAJ-2315) | Olympus Medical Systems Corp. | 2026-02-22 | 94 | 0 |
| K251867 | EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190 | Olympus Medical Systems Corp. | 2025-09-19 | 94 | 1 |
| K250701 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190 | Olympus Medical Systems Corp. | 2025-06-05 | 90 | 0 |
| K233942 | PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medi | Pentax of America, Inc. | 2024-08-01 | 231 | 0 |
| K233886 | Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2 | Ambu A/S | 2024-04-16 | 130 | 0 |
| K220587 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V | Olympus Medical Systems Corp. | 2022-05-11 | 71 | 4 |
| K210710 | PENTAX Medical Video Duedenoscope ED34-i10T2 | Pentax of America, Inc. | 2021-04-09 | 30 | 0 |
| K202365 | Pentax Medical Video Duodenoscope ED32-i10 | Pentax of America, Inc. | 2021-04-01 | 225 | 0 |
| K202661 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V | Olympus Medical Systems Corp. | 2020-12-08 | 85 | 1 |
| K203028 | FUJIFILM Distal End Cap | Fujifilm Corporation | 2020-10-30 | 28 | 0 |
| K201098 | Ambu Duodeno System | Ambu Innovation GmbH | 2020-07-17 | 84 | 0 |
| K193182 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V | Olympus Medical Systems Corp. | 2020-01-17 | 60 | 3 |
| K193202 | EXALT Model D Single-Use Duodenoscope, EXALT Controller | Boston Scientific Corporation | 2019-12-13 | 23 | 2 |
| K192245 | Pentax Medical Video Duodenoscope ED34-i10T2 | Pentax of America, Inc. | 2019-11-15 | 88 | 0 |
| K192280 | PENTAX Medical ED-3490TK Video Duodenoscope | Pentax Medical | 2019-10-21 | 60 | 0 |
| K191747 | FUJIFILM Duodenoscope Model ED-580XT | Fujifilm Corporation | 2019-09-27 | 88 | 0 |
| K181745 | FUJIFILM Duodenoscope Model | Fujifilm Corporation | 2019-03-28 | 269 | 0 |
| K182051 | FUJIFILM Duodenoscope Model | Fujifilm Corporation | 2018-10-02 | 63 | 0 |
| K181522 | PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical | Pentax of America, Inc. | 2018-07-09 | 28 | 0 |
| K161222 | PENTAX MEDICAL ED-3490TK, Video Duodenoscope | Pentax Medical | 2018-02-07 | 649 | 1 |
| K163614 | PENTAX Medical ED34-i10T, Video Duodenoscope | Pentax Medical | 2017-09-20 | 272 | 0 |
| K152257 | Fujifilm Duodenoscope Model ED-530XT | Fujifilm Medical Systems U.S.A, Inc. | 2017-07-21 | 711 | 0 |
| K143153 | EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V | Olympus Medical Systems Corp. | 2016-01-15 | 438 | 2 |
| K110833 | CRE BALLOON DILATATION CATHETER | Boston Scientific Corporation | 2011-04-20 | 26 | 6 |
| K092710 | PENTAX ED-3490TK, VIDEO DUODENOSCOPE | Pentax Medical Company | 2009-12-02 | 90 | 1 |
| K080403 | XTJF TYPE Q160VF1 | Olympus Medical Systems Corporation | 2008-05-20 | 96 | 2 |
| K042076 | FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250 | Fujinon, Inc. | 2004-11-18 | 108 | 1 |
| K024033 | XTJF-160AF DUODENOVIDEOSCOPE | Olympus Optical Co., Ltd. | 2002-12-20 | 14 | 0 |
| K980465 | OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSO | Olympus America, Inc. | 1998-04-21 | 75 | 2 |
| K962212 | KARL STORZ FRIMBERGER VARIOGUIDE | KARL STORZ Endoscopy-America, Inc. | 1996-12-13 | 186 | 0 |
| K963056 | ED-3410, VIDEO DUODENOSCOPE | Pentax Precision Instrument Corp. | 1996-10-10 | 65 | 1 |
| K961568 | ED-344OT | Pentax Precision Instrument Corp. | 1996-07-09 | 77 | 0 |
| K942338 | OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES | Olympus Corp. | 1994-11-30 | 198 | 0 |
| K832006 | PENTAX FD-34A DUODENOFIBERSCOPE | Pentax Precision Instrument Corp. | 1983-08-01 | 39 | 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