510(k) · Cleared
Recalled · Class II · 2025Evis Exera Iii Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corp. · FDT Duodenoscope And Accessories, Flexible/Rigid
Cleared on Sep 19, 2025 as substantially equivalent to K250701 (Olympus Medical Systems Corp., 2025) after a 94-day review. Its family tree reaches back 5 generations to 2008. It has been recalled once.
- Decided
- Sep 19, 2025
- Review
- 94 days
- Class
- Class II
- Product code
- FDT
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K080403 (2008). No later device cites it as a predicate yet.
- Root · 5 generations backK080403 XTJF Type Q160VF1Olympus Medical Systems Corporation · 2008 · Recalled
- 4 generations backK143153 Evis Exera II Duodenovideoscope Olympus TJF Type Q180VOlympus Medical Systems Corp. · 2016 · Recalled
- 3 generations backK193182 Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp. · 2020 · Recalled
- 2 generations backK202661 Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp. · 2020 · Recalled
- 1 generation backK250701 Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)Olympus Medical Systems Corp. · 2025
- This deviceK251867 Evis Exera Iii Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)Olympus Medical Systems Corp. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K080403 | XTJF Type Q160VF1 | Olympus Medical Systems Corporation | 2008 | 2 |
| −4 | K143153 | Evis Exera II Duodenovideoscope Olympus TJF Type Q180V | Olympus Medical Systems Corp. | 2016 | 3 |
| −3 | K193182 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V | Olympus Medical Systems Corp. | 2020 | 4 |
| −2 | K202661 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V | Olympus Medical Systems Corp. | 2020 | 1 |
| −1 | K250701 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) | Olympus Medical Systems Corp. | 2025 | — |
| 0 (this device) | K251867 | Evis Exera Iii Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) | Olympus Medical Systems Corp. | 2025 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FDT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FDT device
- #1 K251861 FUJIFILM Endoscope Model ED-S100TP; FUJIFILM…score 13.7 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K250701 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)Summary page 5…Rigid), NWB, FEB Device Panel: Gastroenterology & Urology 3. Predicate Device Information EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V – Olympus K250701 4. Device Description The EVIS EXERA III DUODENOVIDEOSCOPE TJF-Q190V has been designed to be used with a video system center, l… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 14, 2025 | Class II | Z-0579-2026 | Device Design | Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes, reminding users to… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- 4 of the 5 ancestors have a recall of any class.
How does its category compare?
All FDT devicesFDT Duodenoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · FDT
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FDT
72in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FDT
7so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FDT
3,946in 2025
MAUDE reports naming product code FDT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 4 |
| 2008 | 1 | — | 0 | 11 |
| 2009 | 1 | — | 0 | 18 |
| 2010 | 0 | — | 0 | 12 |
| 2011 | 1 | — | 0 | 10 |
| 2012 | 0 | — | 0 | 15 |
| 2013 | 0 | — | 0 | 18 |
| 2014 | 0 | — | 0 | 36 |
| 2015 | 0 | — | 1 | 246 |
| 2016 | 1 | — | 1 | 247 |
| 2017 | 2 | — | 0 | 791 |
| 2018 | 3 | 63 | 1 | 481 |
| 2019 | 5 | 88 | 0 | 1,347 |
| 2020 | 4 | 72 | 0 | 822 |
| 2021 | 2 | — | 1 | 1,270 |
| 2022 | 1 | — | 0 | 2,619 |
| 2023 | 0 | — | 3 | 3,050 |
| 2024 | 2 | — | 0 | 3,019 |
| 2025 | 2 | — | 1 | 3,946 |
| 2026 | 2 | — | 7 | — |
What is it indicated for?
The EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V has been designed to be used with a video system center, light source, documentation equipment, monitor, endo therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251867 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251867: Evis Exera Iii Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251867
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026