510(k) · Cleared
Recalled · Class II · 2023Evis Exera II Duodenovideoscope Olympus TJF Type Q180V
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 Jan 15, 2016 as substantially equivalent to K080403 (Olympus Medical Systems Corporation, 2008) after a 438-day review. Its family tree reaches back 1 generation to 2008. 14 later devices descend from it. It has been recalled 3 times.
- Decided
- Jan 15, 2016
- Review
- 438 days
- Class
- Class II
- Product code
- FDT
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K080403 (2008). 14 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK080403 XTJF Type Q160VF1Olympus Medical Systems Corporation · 2008 · Recalled
- This deviceK143153 Evis Exera II Duodenovideoscope Olympus TJF Type Q180VOlympus Medical Systems Corp. · 2016
- Descendant · cites it directly · 5 of its ownK193182 Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp. · 2020 · Recalled
- Descendant · 2 generations on · 4 of its ownK202661 Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp. · 2020 · Recalled
- Descendant · cites it directly · 4 of its ownK193202 EXALT Model D Single-Use Duodenoscope, EXALT ControllerBoston Scientific Corporation · 2019 · Recalled
- Descendant · 2 generations on · 3 of its ownK213606 EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK201098 Ambu Duodeno SystemAmbu Innovation GmbH · 2020
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K193182Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp. · 2020 · cites it directly5descendants
- K202661Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp. · 2020 · 2 generations on4descendants
- K193202EXALT Model D Single-Use Duodenoscope, EXALT ControllerBoston Scientific Corporation · 2019 · cites it directly4descendants
- K213606EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc. · 2022 · 2 generations on3descendants
- K201098Ambu Duodeno SystemAmbu Innovation GmbH · 2020 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K080403 | XTJF Type Q160VF1 | Olympus Medical Systems Corporation | 2008 | 2 |
| 0 (this device) | K143153 | Evis Exera II Duodenovideoscope Olympus TJF Type Q180V | Olympus Medical Systems Corp. | 2016 | — |
| +1 | 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 | K193202 | EXALT Model D Single-Use Duodenoscope, EXALT Controller | Boston Scientific Corporation | 2019 | 6 |
| +2 | K213606 | EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. | 2022 | — |
| +1 | K201098 | Ambu Duodeno System | Ambu Innovation GmbH | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K080403 | XTJF Type Q160VF1Summary page 5…ope, accessories, narrow band spectrum III. Predicate Device Information Device Trade Name: XTJF Q160VF1 DUODENOVIDEOSCOPE 510(k) Number K080403 Decision Date 05/20/2008 Manufacturer AIZU OLYMPUS CO., LTD IV. Device Description T… | 2008 |
What descends from it? (14)
See all 144 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 25, 2023 | Class II | Z-0346-2024 | Under Investigation by firm | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead… |
| Nov 2, 2021 | Class II | Z-0379-2022 | Under Investigation by firm | Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope contamination due to ineffective reprocessing or fluid invasion; contaminated endoscope can present an infection risk to patients. |
| Dec 17, 2018 | Class II | Z-1010-2019 | Under Investigation by firm | The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the gluing operation for the endoscope repair. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K193182 (Olympus Medical Systems Corp., 2020) has gone furthest, with 5 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. 2016, 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, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K143153 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143153: Evis Exera II Duodenovideoscope Olympus TJF Type Q180V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143153
Report an extraction error
Are you the manufacturer?
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