510(k) · Cleared
ClearedFUJIFILM Endoscope Model EI-740D/S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Corporaton · FDS Gastroscope And Accessories, Flexible/Rigid
Cleared on Jan 27, 2023 as substantially equivalent to K210162 (Fujifilm Corporation, 2021) after a 241-day review. Its family tree reaches back 5 generations to 1995. 2 later devices descend from it.
- Decided
- Jan 27, 2023
- Review
- 241 days
- Class
- Class II
- Product code
- FDS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K944759 (1995). 7 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK944759 200 Series Gastro-Intestinal Video SystemFujinon, Inc. · 1995 · Recalled
- 4 generations backK041903 Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5Fujinon, Inc. · 2004 · Recalled
- 3 generations backK112391 Fujinon ColonoscopesFujinon, Inc. · 2012
- 2 generations backK142629 EG-530CT, EG-530D, EC-530DL, and ES-530WE EndoscopesFujifilm Medical System U.S.A., Inc. · 2015
- 1 generation backK210162 Endoscope Model EI-740D/SFujifilm Corporation · 2021
- This deviceK221551 FUJIFILM Endoscope Model EI-740D/SFujifilm Corporaton · 2023
- Descendant · cites it directly · 0 of its ownK260824 Gastrointestinal Videoscope Olympus GIF-2T1500Olympus Medical Systems Corporation · 2026
- Descendant · cites it directly · 0 of its ownK233321 Double Balloon Endoscope EN-840T, Over-tube TS-1214CFUJIFILM Healthcare Americas Corporation · 2024
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 |
|---|---|---|---|---|---|
| −5 | K944759 | 200 Series Gastro-Intestinal Video System | Fujinon, Inc. | 1995 | 5 |
| −4 | K041903 | Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5 | Fujinon, Inc. | 2004 | 1 |
| −3 | K112391 | Fujinon Colonoscopes | Fujinon, Inc. | 2012 | — |
| −2 | K142629 | EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes | Fujifilm Medical System U.S.A., Inc. | 2015 | — |
| −1 | K210162 | Endoscope Model EI-740D/S | Fujifilm Corporation | 2021 | — |
| 0 (this device) | K221551 | FUJIFILM Endoscope Model EI-740D/S | Fujifilm Corporaton | 2023 | — |
| +1 | K260824 | Gastrointestinal Videoscope Olympus GIF-2T1500 | Olympus Medical Systems Corporation | 2026 | — |
| +1 | K233321 | Double Balloon Endoscope EN-840T, Over-tube TS-1214C | FUJIFILM Healthcare Americas Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 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? (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 |
|---|---|---|---|
| * | K210162 | Endoscope Model EI-740D/SSummary page 4…ption: Endoscope and accessories Review Panel: Gastroenterology/Urology Predicate Device(s): • Endoscope Model EI-740D/S (K210162) Intended Use / Indications for Use: FUJIFILM Endoscope Model EI-740D/S is intended for the visualization of the upper digestiv… | 2021 |
| † | K203717 | Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0 | 2021 |
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)
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 28 years and passes through 4 companies; a new generation was cleared every 5.9 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K260824 (Olympus Medical Systems Corporation, 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K210162.
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. 2023, 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?
FUJIFILM Endoscope Model EI-740D/S 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 device is also intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and sigmoid colon.
Never use this product for any other purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221551 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221551: FUJIFILM Endoscope Model EI-740D/S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221551
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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