510(k) · Cleared
ClearedGastrointestinal Videoscope Xgif-Q14OM, Xgif-2T140M Colonovideoscope XCF-Q14ML/I, XPCF-160AML/I
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Opto-Electronics Co., Ltd. · FDS Gastroscope And Accessories, Flexible/Rigid
Cleared on Oct 2, 2003 as substantially equivalent to K954451 (Olympus America, Inc., 1996) and 1 other predicate after a 78-day review. Its family tree reaches back 2 generations to 1986. 15 later devices descend from it.
- Decided
- Oct 2, 2003
- Review
- 78 days
- Class
- Class II
- Product code
- FDS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K853585 (1986). 4 ancestors in all. 15 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK853585 Olympus Evs-Endoscopic Video Image & Data SysOlympus Corp. · 1986 · Recalled
- 1 generation backK954451 Evis 140 SystemOlympus America, Inc. · 1996 · Recalled
- This deviceK032177 Gastrointestinal Videoscope Xgif-Q14OM, Xgif-2T140M Colonovideoscope…Olympus Opto-Electronics Co., Ltd. · 2003
- Descendant · cites it directly · 13 of its ownK070330 Third Eye Retroscope Auxiliary Endoscopy SystemAvantis Medical Systems, Inc. · 2007
- Descendant · 2 generations on · 6 of its ownK100624 Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012
- Descendant · 3 generations on · 5 of its ownK121582 Invendo C25 Colonoscopy SystemInvendo Medical Gbmh · 2012
- Descendant · 2 generations on · 5 of its ownK083180 Third Eye Retroscope Auxiliary Endoscopy SystemAvantis Medical Systems, Inc. · 2009
- Descendant · 3 generations on · 4 of its ownK091783 Third Eye Retroscope Auxiliary Endoscope SystemAvantis Medical Systems, Inc. · 2009
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K070330Third Eye Retroscope Auxiliary Endoscopy SystemAvantis Medical Systems, Inc. · 2007 · cites it directly13descendants
- K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012 · 2 generations on6descendants
- K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh · 2012 · 3 generations on5descendants
- K083180Third Eye Retroscope Auxiliary Endoscopy SystemAvantis Medical Systems, Inc. · 2009 · 2 generations on5descendants
- K091783Third Eye Retroscope Auxiliary Endoscope SystemAvantis Medical Systems, Inc. · 2009 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K853585 | Olympus Evs-Endoscopic Video Image & Data Sys | Olympus Corp. | 1986 | 2 |
| −1 | K954451 | Evis 140 System | Olympus America, Inc. | 1996 | 3 |
| 0 (this device) | K032177 | Gastrointestinal Videoscope Xgif-Q14OM, Xgif-2T140M Colonovideoscope… | Olympus Opto-Electronics Co., Ltd. | 2003 | — |
| +1 | K070330 | Third Eye Retroscope Auxiliary Endoscopy System | Avantis Medical Systems, Inc. | 2007 | — |
| +2 | K100624 | Invendo C20 Colonoscopy System | Invendo Medical Gbmh | 2012 | — |
| +3 | K121582 | Invendo C25 Colonoscopy System | Invendo Medical Gbmh | 2012 | — |
| +2 | K083180 | Third Eye Retroscope Auxiliary Endoscopy System | Avantis Medical Systems, Inc. | 2009 | — |
| +3 | K091783 | Third Eye Retroscope Auxiliary Endoscope System | Avantis Medical Systems, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 3 | 0 |
| 2012 | 3 | 0 |
| 2014 | 2 | 0 |
| 2016 | 3 | 0 |
| 2018 | 2 | 0 |
| 2020 | 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.
What descends from it? (15)
See all 152 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 17 years and passes through 3 companies; a new generation was cleared every 10.2 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K070330 (Avantis Medical Systems, Inc., 2007) has gone furthest, with 13 descendants of its own.
- 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.
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 instrument has been designed to be used with the OLYMPUS Video System Center, Light Source, Documentation Equipment, Video Monitor, Electrosurgical unit, Endo-Therapy Accessories such as a Biopsy Forceps and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach and duodenum). This instrument has been designed to be used with the OLYMPUS Video System Center, Light Source…
Read the full statement (103 words)
This instrument has been designed to be used with the OLYMPUS Video System Center, Light Source, Documentation Equipment, Video Monitor, Electrosurgical unit, Endo-Therapy Accessories such as a Biopsy Forceps and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach and duodenum).
This instrument has been designed to be used with the OLYMPUS Video System Center, Light Source, Documentation Equipment, Video Monitor, Electrosurgical unit, Endo-Therapy Accessories such as a Biopsy Forceps and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, and sigmoid colon, colon, and ileocecal valve).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032177 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032177: Gastrointestinal Videoscope Xgif-Q14OM, Xgif-2T140M Colonovideoscope XCF-Q14ML/I, XPCF-160AML/I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032177
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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