510(k) · Cleared
Recalled · Class II · 2016XTJF-160AF Duodenovideoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Optical Co., Ltd. · FDT Duodenoscope And Accessories, Flexible/Rigid
Cleared on Dec 20, 2002 as substantially equivalent to K980465 (Olympus America, Inc., 1998) and 2 other predicates after a 14-day review. Its family tree reaches back 3 generations to 1986. It has been recalled once.
- Decided
- Dec 20, 2002
- Review
- 14 days
- Class
- Class II
- Product code
- FDT
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K853585 (1986). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK853585 Olympus Evs-Endoscopic Video Image & Data SysOlympus Corp. · 1986 · Recalled
- 2 generations backK954451 Evis 140 SystemOlympus America, Inc. · 1996 · Recalled
- 1 generation backK980465 Olympus TJF-140R/JF-140R Evis Duodenovideoscopes and Accessories…Olympus America, Inc. · 1998 · Recalled
- This deviceK024033 XTJF-160AF DuodenovideoscopeOlympus Optical Co., Ltd. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K853585 | Olympus Evs-Endoscopic Video Image & Data Sys | Olympus Corp. | 1986 | 2 |
| −2 | K954451 | Evis 140 System | Olympus America, Inc. | 1996 | 3 |
| −1 | K980465 | Olympus TJF-140R/JF-140R Evis Duodenovideoscopes and Accessories, Olympus… | Olympus America, Inc. | 1998 | 2 |
| 0 (this device) | K024033 | XTJF-160AF Duodenovideoscope | Olympus Optical Co., Ltd. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2000 | 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? (3)
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 |
|---|---|---|---|
| * | K980465 | Olympus TJF-140R/JF-140R Evis Duodenovideoscopes and Accessories, Olympus…Summary page 4…as predicate devices in consideration of its characteristic and the following table shows regulatory history. Model #510(k) Manufacturer Class | Product Code TJF-140R #K980465 | Olympus Optical Co., | 78-KOG Duodenovideoscope JF-V10 #K853585 | Olympus Optical Co., 1 78-KOG Videoimage Duodenoscope EVIS EX… | 1998 |
| * | K853585 | Olympus Evs-Endoscopic Video Image & Data SysSummary page 4…he following table shows regulatory history. Model #510(k) Manufacturer Class | Product Code TJF-140R #K980465 | Olympus Optical Co., | 78-KOG Duodenovideoscope JF-V10 #K853585 | Olympus Optical Co., 1 78-KOG Videoimage Duodenoscope EVIS EXERA #K001241 | Olympus Optical Co., n 78-KOG Colonovideoendoscopes… | 1986 |
| * | K001241 | Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/ISummary page 4…ss | Product Code TJF-140R #K980465 | Olympus Optical Co., | 78-KOG Duodenovideoscope JF-V10 #K853585 | Olympus Optical Co., 1 78-KOG Videoimage Duodenoscope EVIS EXERA #K001241 | Olympus Optical Co., n 78-KOG Colonovideoendoscopes C. Summary Description of the Device 1. Summary This prem… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 15, 2016 | Class II | Z-1845-2016 | Under Investigation by firm | New reprocessing instructions for the Olympus TJF-160/VF duodenoscopes, consisting of revised manual cleaning and high level disinfection procedures they plan to implement as well as a new cleaning brush (MAJ-1534), which is enclosed with… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 4 of the 5 ancestors have a recall of any class.
- 1 other device also cites its predicate K980465.
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?
The XTJF-160AF has been designed to be used with an Olympus EVIS video system cenler, light source, Documentation Equipment, Video Monitor, Endo-Therapy accessories (such as a Forceps, Eleclrosurgical Accessories, etc.), Electrosurgical Unit, and other Ancillary Equipment for endoscopy and endoscopic surgery within the duodenum.
Do not use these instruments for any purpose other than their intended uses.
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/K024033 · printed Nov 6, 2026
Cite this page
510(k) Report. “K024033: XTJF-160AF Duodenovideoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024033
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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