510(k) · Cleared
ClearedFUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Corporation · FDS Gastroscope And Accessories, Flexible/Rigid
Cleared on Feb 17, 2026 as substantially equivalent to K954451 (Olympus America, Inc., 1996) and 1 other predicate after a 357-day review. Its family tree reaches back 4 generations to 1986.
- Decided
- Feb 17, 2026
- Review
- 357 days
- Class
- Class II
- Product code
- FDS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K853585 (1986). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK853585 Olympus Evs-Endoscopic Video Image & Data SysOlympus Corp. · 1986 · Recalled
- 3 generations backK954451 Evis 140 SystemOlympus America, Inc. · 1996 · Recalled
- 2 generations backK051645 Evis Exera 160A SystemOlympus Medical Systems Corporation · 2005 · Recalled
- 1 generation backK072957 Evis Exera II 180 SystemOlympus Medical Systems Corporation · 2008 · Recalled
- This deviceK250550 FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFujifilm Corporation · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K853585 | Olympus Evs-Endoscopic Video Image & Data Sys | Olympus Corp. | 1986 | 2 |
| −3 | K954451 | Evis 140 System | Olympus America, Inc. | 1996 | 3 |
| −2 | K051645 | Evis Exera 160A System | Olympus Medical Systems Corporation | 2005 | 3 |
| −1 | K072957 | Evis Exera II 180 System | Olympus Medical Systems Corporation | 2008 | 1 |
| 0 (this device) | K250550 | FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit | Fujifilm Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 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 FDS? 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 FDS device
- #1 K251708 EvoEndo Single-Use Endoscopy Systemscore 16.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 5…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code IK954451 I EVIS 140 SYSTEM I FET IK072957 Olympus CV-1… | 1996 |
| * | K072957 | Evis Exera II 180 SystemSummary page 5…de Name (Primary Predicate is listed first) Product Code IK954451 I EVIS 140 SYSTEM I FET IK072957 Olympus CV-180/CLV-180 INWB Device Description Summ… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 40 years and passes through 4 companies; a new generation was cleared every 10.2 years on median.
- 6 of the 8 ancestors have a recall of any class.
- 9 other devices also cite its predicate K954451.
How does its category compare?
All FDS devicesFDS Gastroscope 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 · FDS
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FDS
211in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FDS
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FDS
18,905in 2025
MAUDE reports naming product code FDS, 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 | 2 | — | 0 | 27 |
| 2008 | 0 | — | 0 | 11 |
| 2009 | 0 | — | 0 | 21 |
| 2010 | 1 | — | 0 | 45 |
| 2011 | 1 | — | 0 | 36 |
| 2012 | 3 | 181 | 0 | 35 |
| 2013 | 2 | — | 1 | 8 |
| 2014 | 2 | — | 0 | 23 |
| 2015 | 2 | — | 0 | 29 |
| 2016 | 1 | — | 1 | 108 |
| 2017 | 1 | — | 0 | 178 |
| 2018 | 6 | 167 | 0 | 304 |
| 2019 | 5 | 175 | 0 | 1,376 |
| 2020 | 2 | — | 2 | 601 |
| 2021 | 5 | 78 | 0 | 1,755 |
| 2022 | 2 | — | 0 | 6,216 |
| 2023 | 3 | 133 | 0 | 9,874 |
| 2024 | 5 | 220 | 2 | 9,258 |
| 2025 | 8 | 211 | 0 | 18,905 |
| 2026 | 7 | 164 | 0 | — |
What is it indicated for?
This product is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
This product is a non-sterile, reusable display device designed to display live image data from FUJIFILM single-use endoscope.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250550 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250550: FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250550
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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