510(k) · Cleared
ClearedFUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Corporation · FDT Duodenoscope And Accessories, Flexible/Rigid
Cleared on Mar 9, 2026 as substantially equivalent to K980465 (Olympus America, Inc., 1998) and 3 other predicates after a 265-day review. Its family tree reaches back 10 generations to 1993. 3 of the 42 devices in its family, counting itself, have a Class I recall.
- Decided
- Mar 9, 2026
- Review
- 265 days
- Class
- Class II
- Product code
- FDT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K931154 (1993). 41 ancestors in all, the oldest K843084 (1985). No later device cites it as a predicate yet. 3 of the 42 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 6 generations between
- 3 generations backK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- 2 generations backK201098 Ambu Duodeno SystemAmbu Innovation GmbH · 2020
- 1 generation backK233886 Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2Ambu A/S · 2024
- This deviceK251861 FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model…Fujifilm Corporation · 2026
Show all 10 generations
- Root · 10 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 9 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 8 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 7 generations backK013591 Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary…Olympus Optical Co., Ltd. · 2001
- 6 generations backK021073 Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc. · 2002
- 5 generations backK031648 Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd. · 2003
- 4 generations backK061313 Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Recalled (Class I)
- 3 generations backK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- 2 generations backK201098 Ambu Duodeno SystemAmbu Innovation GmbH · 2020
- 1 generation backK233886 Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2Ambu A/S · 2024
- This deviceK251861 FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model…Fujifilm Corporation · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −9 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −8 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −7 | K013591 | Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment | Olympus Optical Co., Ltd. | 2001 | — |
| −6 | K021073 | Visera Rhinlaryngovideoscope Olympus Enf Type V | Olympus America, Inc. | 2002 | — |
| −5 | K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type V | Olympus Optical Co., Ltd. | 2003 | — |
| −4 | K061313 | Evis Exera 180 System | Olympus Medical Systems Corporation | 2006 | Class I |
| −3 | K100584 | Evis Exeraii 180 System | Olympus Medical Systems Corporation | 2010 | 9 |
| −2 | K201098 | Ambu Duodeno System | Ambu Innovation GmbH | 2020 | — |
| −1 | K233886 | Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2 | Ambu A/S | 2024 | — |
| 0 (this device) | K251861 | FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP… | Fujifilm Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1991 | 2 | 1 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2023 | 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.
3 devices in this family have a Class I recall. 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 K250701 Evis Exera III Duodenovideoscope Olympus…score 13.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 5….1500 Product Code(s) FDT, FET I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K980465 Olympus TJF-140R/JF-140R Duodenovideoscopes FDT K191747 FUJIFILM Duodenoscope Model ED-580XT FDT K233886 Ambu® aScope™ Duodeno 2… | 1998 |
| * | K191747 | FUJIFILM Duodenoscope Model ED-580XTSummary page 5…ate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K980465 Olympus TJF-140R/JF-140R Duodenovideoscopes FDT K191747 FUJIFILM Duodenoscope Model ED-580XT FDT K233886 Ambu® aScope™ Duodeno 2 FDT K072957 Olympus CV-180/CLV-180 NWB Device Descriptio… | 2019 |
| * | K233886 | Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2Summary page 5…cate Trade Name (Primary Predicate is listed first) Product Code K980465 Olympus TJF-140R/JF-140R Duodenovideoscopes FDT K191747 FUJIFILM Duodenoscope Model ED-580XT FDT K233886 Ambu® aScope™ Duodeno 2 FDT K072957 Olympus CV-180/CLV-180 NWB Device Description Summary 21 CFR 807.92(a)(4) A. Intended Use/in… | 2024 |
| * | K072957 | Evis Exera II 180 SystemSummary page 5…s listed first) Product Code K980465 Olympus TJF-140R/JF-140R Duodenovideoscopes FDT K191747 FUJIFILM Duodenoscope Model ED-580XT FDT K233886 Ambu® aScope™ Duodeno 2 FDT K072957 Olympus CV-180/CLV-180 NWB Device Description Summary 21 CFR 807.92(a)(4) A. Intended Use/indications for Use K2… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K061313Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · 4 generations back · ◆ on the line of descent in FIG. 16 Class I recalls
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 5 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 6 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 33 years and passes through 8 companies; a new generation was cleared every 3.1 years on median.
- 24 of the 41 ancestors have a recall of any class; 3 have a Class I recall.
- 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. 2026, 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?
a) ED-S100TP, ED-S100XP
This product has been designed for endoscopy and endoscopic surgery within the duodenum.
b) VS-1000
This product is a non-sterile, reusable display device designed to display live image data from
FUJIFILM single-use endoscope.
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/K251861 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251861: FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251861
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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