510(k) · Cleared
ClearedGastrointestinal Videoscope Olympus GIF-2T1500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corporation · FDS Gastroscope And Accessories, Flexible/Rigid
Cleared on Aug 27, 2026 as substantially equivalent to K221551 (Fujifilm Corporaton, 2023) after a 167-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Aug 27, 2026
- Review
- 167 days
- Class
- Class II
- Product code
- FDS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K944759 (1995). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK944759 200 Series Gastro-Intestinal Video SystemFujinon, Inc. · 1995 · Recalled
- 5 generations backK041903 Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5Fujinon, Inc. · 2004 · Recalled
- 4 generations backK112391 Fujinon ColonoscopesFujinon, Inc. · 2012
- 3 generations backK142629 EG-530CT, EG-530D, EC-530DL, and ES-530WE EndoscopesFujifilm Medical System U.S.A., Inc. · 2015
- 2 generations backK210162 Endoscope Model EI-740D/SFujifilm Corporation · 2021
- 1 generation backK221551 FUJIFILM Endoscope Model EI-740D/SFujifilm Corporaton · 2023
- This deviceK260824 Gastrointestinal Videoscope Olympus GIF-2T1500Olympus Medical Systems Corporation · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K944759 | 200 Series Gastro-Intestinal Video System | Fujinon, Inc. | 1995 | 5 |
| −5 | K041903 | Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5 | Fujinon, Inc. | 2004 | 1 |
| −4 | K112391 | Fujinon Colonoscopes | Fujinon, Inc. | 2012 | — |
| −3 | K142629 | EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes | Fujifilm Medical System U.S.A., Inc. | 2015 | — |
| −2 | K210162 | Endoscope Model EI-740D/S | Fujifilm Corporation | 2021 | — |
| −1 | K221551 | FUJIFILM Endoscope Model EI-740D/S | Fujifilm Corporaton | 2023 | — |
| 0 (this device) | K260824 | Gastrointestinal Videoscope Olympus GIF-2T1500 | Olympus Medical Systems Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K221551 | FUJIFILM Endoscope Model EI-740D/SSummary page 5…ssification Class II III. Predicate Device Substantial equivalence is claimed to the following device: • FUJIFILM Endoscope Model EI-740D/S, K221551, Fujifilm Corporation IV. Device Description The Gastrointestinal Videoscope Olympus GIF-2T1500 (GIF-2T1500) is a non-st… | 2023 |
| † | K112680 | Evis Exera Iii Video System | 2012 |
| † | K232997 | EVIS Exera III Gastrointestinal Videoscope GIF-1TH190 | 2024 |
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 31 years and passes through 5 companies; a new generation was cleared every 5.9 years on median.
- 3 of the 8 ancestors have a recall of any class.
- 1 other device also cites its predicate K221551.
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?
The GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-2T1500 is intended to be used with a video system center, documentation equipment, monitor, endoscopic therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).
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/K260824 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260824: Gastrointestinal Videoscope Olympus GIF-2T1500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260824
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026