510(k) · Cleared
Recalled · Class II · 2023Olympus TJF-140R/JF-140R Evis Duodenovideoscopes and Accessories, Olympus Maj-311/Maj-411 Distal Covers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus America, Inc. · FDT Duodenoscope And Accessories, Flexible/Rigid
Cleared on Apr 21, 1998 as substantially equivalent to K954451 (Olympus America, Inc., 1996) after a 75-day review. Its family tree reaches back 2 generations to 1986. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 21, 1998
- Review
- 75 days
- Class
- Class II
- Product code
- FDT
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K853585 (1986). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK853585 Olympus Evs-Endoscopic Video Image & Data SysOlympus Corp. · 1986 · Recalled
- 1 generation backK954451 Evis 140 SystemOlympus America, Inc. · 1996 · Recalled
- This deviceK980465 Olympus TJF-140R/JF-140R Evis Duodenovideoscopes and Accessories…Olympus America, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK251861 FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model…Fujifilm Corporation · 2026
- Descendant · cites it directly · 0 of its ownK024033 XTJF-160AF DuodenovideoscopeOlympus Optical Co., Ltd. · 2002 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K853585 | Olympus Evs-Endoscopic Video Image & Data Sys | Olympus Corp. | 1986 | 2 |
| −1 | K954451 | Evis 140 System | Olympus America, Inc. | 1996 | 3 |
| 0 (this device) | K980465 | Olympus TJF-140R/JF-140R Evis Duodenovideoscopes and Accessories, Olympus… | Olympus America, Inc. | 1998 | — |
| +1 | K251861 | FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP… | Fujifilm Corporation | 2026 | — |
| +1 | K024033 | XTJF-160AF Duodenovideoscope | Olympus Optical Co., Ltd. | 2002 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 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 |
|---|---|---|---|
| * | K954451 | Evis 140 SystemSummary page 1…Olympus EVIS Duodenovideoscopes Classification Name: 21 CFR 876.1500, Class II Endoscopes and Accessories. Predicate Devices: Olympus TJF-140 EVIS Duodenovideoscope (K954451) Olympus JF-140 EVIS Duodenovideoscope (K954451) Olympus MH-880 Distal Cover (K954451) Olympus MH-975 Distal Cover (K954451) Pre… | 1996 |
What descends from it? (2)
2 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-0342-2024 | 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… |
| Sep 25, 2023 | Class II | Z-0341-2024 | 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… |
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 10.2 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K251861 (Fujifilm Corporation, 2026) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K954451.
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.
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?
Olympus TJF-140R/JF-140R Duodenovideoscopes have been designed to be used with an Olympus EVIS Video System Center, light source, documentation equipment, video monitor, Endo-Therapy Accessories (Forceps, Brush, Electrosurgical Accessories, etc.), Electrosurgical Unit, and other Ancillary Equipment for endoscopy and endoscopic surgery within the duodenum.
Olympus MAJ-311 Distal Cover is specifically designed to be attached to the Olympus TJF-140R Duodenovideoscope during an endoscopic procedure. Olympus MAJ-411 Distal Cover is specifically designed to be attached to the Olympus JF-140R Duodenovideoscope during an endoscopic procedure.
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/K980465 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980465: Olympus TJF-140R/JF-140R Evis Duodenovideoscopes and Accessories, Olympus Maj-311/Maj-411 Distal Covers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980465
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