510(k) · Cleared
Recalled · Class II · 2026Evis Exera III Duodenovideoscope Olympus 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 May 11, 2022 as substantially equivalent to K202661 (Olympus Medical Systems Corp., 2020) after a 71-day review. Its family tree reaches back 4 generations to 2008. 1 later device descends from it. It has been recalled 4 times.
- Decided
- May 11, 2022
- Review
- 71 days
- Class
- Class II
- Product code
- FDT
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 4 generations to K080403 (2008). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK080403 XTJF Type Q160VF1Olympus Medical Systems Corporation · 2008 · Recalled
- 3 generations backK143153 Evis Exera II Duodenovideoscope Olympus TJF Type Q180VOlympus Medical Systems Corp. · 2016 · Recalled
- 2 generations backK193182 Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp. · 2020 · Recalled
- 1 generation backK202661 Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp. · 2020 · Recalled
- This deviceK220587 Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp. · 2022
- Descendant · cites it directly · 0 of its ownK253646 Single Use Distal Cover MAJ-2315 (MAJ-2315)Olympus Medical Systems Corp. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253646Single Use Distal Cover MAJ-2315 (MAJ-2315)Olympus Medical Systems Corp. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K080403 | XTJF Type Q160VF1 | Olympus Medical Systems Corporation | 2008 | 2 |
| −3 | 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 |
| −1 | K202661 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V | Olympus Medical Systems Corp. | 2020 | 1 |
| 0 (this device) | K220587 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V | Olympus Medical Systems Corp. | 2022 | — |
| +1 | K253646 | Single Use Distal Cover MAJ-2315 (MAJ-2315) | Olympus Medical Systems Corp. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 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 |
|---|---|---|---|
| * | K202661 | Evis Exera III Duodenovideoscope Olympus TJF-Q190VSummary page 5…Device name 510(k) Submitter 510(k) No. EVIS EXERA III OLYMPUS MEDICAL K202661 DUODENOVIDEOSCOPE SYSTEMS CORP. OLYMPUS TJF TYPE Q190V 4. Device Description The EVIS EXERA III DUODENOSCOP… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253646 | Single Use Distal Cover MAJ-2315 (MAJ-2315) | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 5, 2026 | Class II | Z-2676-2026 | Device Design | Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers. |
| May 5, 2025 | Class II | Z-1911-2025 | Labeling design | Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one hour and a presoak was performed, compared to those TJF… |
| Dec 8, 2023 | Class II | Z-1071-2024 | Device Design | Single Use Distal Cover MAJ-2315 may unexpectedly detach from the duodenoscope during use result include the risk of mucosal injury, tissue damage, bleeding, perforation, or obstruction due to retained distal cover in the gastrointestinal… |
| Jul 27, 2023 | Class II | Z-2467-2023 | Under Investigation by firm | Recent reports of patient infection. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- 4 of the 4 ancestors have a recall of any class.
- Of its descendants, K253646 (Olympus Medical Systems Corp., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K202661.
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. 2022, 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/K220587 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220587: Evis Exera III Duodenovideoscope Olympus TJF-Q190V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220587
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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