510(k) · Cleared
Recalled · Class II · 2016XTJF Type Q160VF1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corporation · FDT Duodenoscope And Accessories, Flexible/Rigid
Cleared on May 20, 2008 after a 96-day review. The FDA summary names its predicate without a number. 15 later devices descend from it. It has been recalled 2 times.
- Decided
- May 20, 2008
- Review
- 96 days
- Class
- Class II
- Product code
- FDT
- Recalls
- 2
- Predicates
- 0
15 later devices descend from it, 1 citing it directly.
- This deviceK080403 XTJF Type Q160VF1Olympus Medical Systems Corporation · 2008
- Descendant · cites it directly · 14 of its ownK143153 Evis Exera II Duodenovideoscope Olympus TJF Type Q180VOlympus Medical Systems Corp. · 2016 · Recalled
- Descendant · 2 generations on · 5 of its ownK193182 Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp. · 2020 · Recalled
- Descendant · 3 generations on · 4 of its ownK202661 Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp. · 2020 · Recalled
- Descendant · 2 generations on · 4 of its ownK193202 EXALT Model D Single-Use Duodenoscope, EXALT ControllerBoston Scientific Corporation · 2019 · Recalled
- Descendant · 3 generations on · 3 of its ownK213606 EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc. · 2022
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K143153Evis Exera II Duodenovideoscope Olympus TJF Type Q180VOlympus Medical Systems Corp. · 2016 · cites it directly14descendants
- K193182Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp. · 2020 · 2 generations on5descendants
- K202661Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp. · 2020 · 3 generations on4descendants
- K193202EXALT Model D Single-Use Duodenoscope, EXALT ControllerBoston Scientific Corporation · 2019 · 2 generations on4descendants
- K213606EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc. · 2022 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K080403 | XTJF Type Q160VF1 | Olympus Medical Systems Corporation | 2008 | — |
| +1 | K143153 | Evis Exera II Duodenovideoscope Olympus TJF Type Q180V | Olympus Medical Systems Corp. | 2016 | 3 |
| +2 | K193182 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V | Olympus Medical Systems Corp. | 2020 | 4 |
| +3 | K202661 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V | Olympus Medical Systems Corp. | 2020 | 1 |
| +2 | K193202 | EXALT Model D Single-Use Duodenoscope, EXALT Controller | Boston Scientific Corporation | 2019 | 6 |
| +3 | K213606 | EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 0 |
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 |
|---|---|---|---|
| * | — | Olympus XTJF Type 160AF Duodenovideoscope Named without a submission number |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143153 | Evis Exera II Duodenovideoscope Olympus TJF Type Q180V | 2016 | 14 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 8, 2016 | Class II | Z-0757-2016 | No Marketing Application | Olympus America Inc is conducting a voluntary removal/corrective action of all TJF-Q180V duodenoscopes in order to replace the forceps elevator mechanism Olympus is replacing the forceps elevator mechanism with a new forceps elevator… |
| Mar 26, 2015 | Class II | Z-2807-2015 | Labeling design | New and validated reprocessing procedures have been issued for the Olympus TJF-Q180V duodenoscope ("TJF-Q180V"), consisting of revised manual cleaning and high level disinfection procedures. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K143153 (Olympus Medical Systems Corp., 2016) has gone furthest, with 14 descendants of its own.
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. 2008, 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?
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, video 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/K080403 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080403: XTJF Type Q160VF1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080403
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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