510(k) · Cleared
Recalled · Class II · 2023Evis 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 Jan 17, 2020 as substantially equivalent to K143153 (Olympus Medical Systems Corp., 2016) after a 60-day review. Its family tree reaches back 2 generations to 2008. 5 later devices descend from it. It has been recalled 4 times.
- Decided
- Jan 17, 2020
- Review
- 60 days
- Class
- Class II
- Product code
- FDT
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 2 generations to K080403 (2008). 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK080403 XTJF Type Q160VF1Olympus Medical Systems Corporation · 2008 · Recalled
- 1 generation backK143153 Evis Exera II Duodenovideoscope Olympus TJF Type Q180VOlympus Medical Systems Corp. · 2016 · Recalled
- This deviceK193182 Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp. · 2020
- Descendant · cites it directly · 4 of its ownK202661 Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp. · 2020 · Recalled
- Descendant · 2 generations on · 1 of its ownK250701 Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)Olympus Medical Systems Corp. · 2025
- Descendant · 2 generations on · 1 of its ownK220587 Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp. · 2022 · Recalled
- Descendant · 3 generations on · 0 of its ownK253646 Single Use Distal Cover MAJ-2315 (MAJ-2315)Olympus Medical Systems Corp. · 2026
- Descendant · 3 generations on · 0 of its ownK251867 Evis Exera Iii Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)Olympus Medical Systems Corp. · 2025 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K202661Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp. · 2020 · cites it directly4descendants
- K250701Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)Olympus Medical Systems Corp. · 2025 · 2 generations on1descendant
- K220587Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp. · 2022 · 2 generations on1descendant
- K253646Single Use Distal Cover MAJ-2315 (MAJ-2315)Olympus Medical Systems Corp. · 2026 · 3 generations on0descendants
- K251867Evis Exera Iii Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)Olympus Medical Systems Corp. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K080403 | XTJF Type Q160VF1 | Olympus Medical Systems Corporation | 2008 | 2 |
| −1 | K143153 | Evis Exera II Duodenovideoscope Olympus TJF Type Q180V | Olympus Medical Systems Corp. | 2016 | 3 |
| 0 (this device) | K193182 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V | Olympus Medical Systems Corp. | 2020 | — |
| +1 | K202661 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V | Olympus Medical Systems Corp. | 2020 | 1 |
| +2 | K250701 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) | Olympus Medical Systems Corp. | 2025 | — |
| +2 | K220587 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V | Olympus Medical Systems Corp. | 2022 | 4 |
| +3 | K253646 | Single Use Distal Cover MAJ-2315 (MAJ-2315) | Olympus Medical Systems Corp. | 2026 | — |
| +3 | K251867 | Evis Exera Iii Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) | Olympus Medical Systems Corp. | 2025 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K143153 | Evis Exera II Duodenovideoscope Olympus TJF Type Q180VSummary page 5…Device name 510(k) Submitter 510(k) No. EVIS EXERA II OLYMPUS MEDICAL K143153 DUODENOVIDEOSCOPE SYSTEMS CORP. OLYMPUS TJF TYPE Q180V 5.4 DEVICE DESCRIPTION EVIS EXERA III DUODENOVIDEOSCO… | 2016 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202661 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V | 2020 | 4 |
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… |
| Jul 27, 2023 | Class II | Z-2467-2023 | Under Investigation by firm | Recent reports of patient infection. |
| Apr 18, 2023 | Class II | Z-1613-2023 | Device Design | The Single Use Distal Cover MAJ-2315 may cause mucosal injury and/or become detached from the endoscope during use. Consequences of a detached cover could include the risk of aspiration, inhalation, or obstruction that will require urgent… |
| Jan 28, 2021 | Class II | Z-1292-2021 | Under Investigation by firm | Olympus Medical Systems Corporation (OMSC) has received complaints of mucosal injury associated with the forceps elevator region of the TJF-Q190V duodenoscope, including the distal cover (model MAJ- 2315). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 7.7 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K202661 (Olympus Medical Systems Corp., 2020) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K143153.
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. 2020, 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 as stated in the FDA summary.
https://510kreport.com/device/K193182 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193182: 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/K193182
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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