510(k) · Cleared
ClearedXsif-1TQ140A Small Intestinal Videoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Opto-Electronics Co., Ltd. · FDA Enteroscope And Accessories
Cleared on Jul 23, 2003 as substantially equivalent to K904800 (Olympus Corp., 1991) and 3 other predicates after a 93-day review. Its family tree reaches back 2 generations to 1986. 5 later devices descend from it.
- Decided
- Jul 23, 2003
- Review
- 93 days
- Class
- Class II
- Product code
- FDA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K853585 (1986). 5 ancestors in all. 5 later devices descend from it, 1 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 deviceK031256 Xsif-1TQ140A Small Intestinal VideoscopeOlympus Opto-Electronics Co., Ltd. · 2003
- Descendant · cites it directly · 4 of its ownK051551 Small Intestinal Videoscope SystemOlympus Medical Systems Corporation · 2005
- Descendant · 2 generations on · 3 of its ownK071254 Small Intestinal Videoscope SystemOlympus Medical Systems Corporation · 2008 · Recalled
- Descendant · 3 generations on · 1 of its ownK231323 Ancora-SBAspero Medical, Inc. · 2023
- Descendant · 4 generations on · 0 of its ownK260314 Ancora-SBAspero Medical, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK091759 Single Use Splinting Tube, Models ST-Y0002-S, ST-Y0002-H, ST-Y0003-S…Olympus Medical Systems Corporation · 2009
Most influential descendants
Showing 5 of 5 · See all- K051551Small Intestinal Videoscope SystemOlympus Medical Systems Corporation · 2005 · cites it directly4descendants
- K071254Small Intestinal Videoscope SystemOlympus Medical Systems Corporation · 2008 · 2 generations on3descendants
- K231323Ancora-SBAspero Medical, Inc. · 2023 · 3 generations on1descendant
- K260314Ancora-SBAspero Medical, Inc. · 2026 · 4 generations on0descendants
- K091759Single Use Splinting Tube, Models ST-Y0002-S, ST-Y0002-H, ST-Y0003-S and ST-Y0003-HOlympus Medical Systems Corporation · 2009 · 3 generations on0descendants
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) | K031256 | Xsif-1TQ140A Small Intestinal Videoscope | Olympus Opto-Electronics Co., Ltd. | 2003 | — |
| +1 | K051551 | Small Intestinal Videoscope System | Olympus Medical Systems Corporation | 2005 | — |
| +2 | K071254 | Small Intestinal Videoscope System | Olympus Medical Systems Corporation | 2008 | 1 |
| +3 | K231323 | Ancora-SB | Aspero Medical, Inc. | 2023 | — |
| +4 | K260314 | Ancora-SB | Aspero Medical, Inc. | 2026 | — |
| +3 | K091759 | Single Use Splinting Tube, Models ST-Y0002-S, ST-Y0002-H, ST-Y0003-S and… | Olympus Medical Systems Corporation | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2023 | 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 FDA? 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 FDA device
- #1 K260314 Ancora-SBscore 13.4 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K904800 | SIF-SW Our OCR of the scanned summary read K304800, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SIF-SW Sonde-type Small Intestinal Fiberscope”. | 1991 |
| * | K001241 | Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/ISummary page 5…tical Co., Ltd. Jil 78-KOG Small Intestinal Fiberscope | Device SIF-SW Sonde-type Small | #K304800 Olympus Optical Co., Ltd. 11 78-KOG Iintestinal Fiberscope EVIS EXERA #K001241 Olympus Optical Co., Ltd. o 78-KOG Colonovideoendoscopes PR-2B(Cannula with Stylet) | #K931154 Olympus Optical Co., Ltd. 1 77-EOQ… | 2000 |
| * | K931154 | Evis 200 SystemSummary page 5…800 Olympus Optical Co., Ltd. 11 78-KOG Iintestinal Fiberscope EVIS EXERA #K001241 Olympus Optical Co., Ltd. o 78-KOG Colonovideoendoscopes PR-2B(Cannula with Stylet) | #K931154 Olympus Optical Co., Ltd. 1 77-EOQ for EVIS-200 System ST-C6/C8 Splinting Tube #K954451 Olympus Optical Co., Ltd. I 78-FDS for EV… | 1993 |
| * | K954451 | Evis 140 SystemSummary page 5…us Optical Co., Ltd. o 78-KOG Colonovideoendoscopes PR-2B(Cannula with Stylet) | #K931154 Olympus Optical Co., Ltd. 1 77-EOQ for EVIS-200 System ST-C6/C8 Splinting Tube #K954451 Olympus Optical Co., Ltd. I 78-FDS for EVIS-140 Series Scopes D. DEVICE DESCRIPTION 1. Summary The subject device, the XSIF-1TQ… | 1996 |
| * | — | SIF-B Small Intestinal Fiberscope Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051551 | Small Intestinal Videoscope System | 2005 | 4 |
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 5 ancestors have a recall of any class.
- Of its descendants, K051551 (Olympus Medical Systems Corporation, 2005) has gone furthest, with 4 descendants of its own.
How does its category compare?
All FDA devicesFDA Enteroscope And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FDA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FDA
Too few FDA 510(k)s in any year since 2007 to give a median.
Recalls per year · FDA
No recall names FDA since 2007.
Adverse event reports per year · FDA
116in 2025
MAUDE reports naming product code FDA, 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 | 1 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 28 |
| 2018 | 0 | — | 0 | 81 |
| 2019 | 2 | — | 0 | 76 |
| 2020 | 1 | — | 0 | 29 |
| 2021 | 1 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 87 |
| 2023 | 2 | — | 0 | 72 |
| 2024 | 1 | — | 0 | 86 |
| 2025 | 1 | — | 0 | 116 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE This instrument has been designed to be used with the OLYMPUS EVIS Video System Center, EVIS Universal Light Source, Documentation Equipment, Video Monitor, Endo-Therapy Accessories (such as a Forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the small intestine. XBO1-681-26 STYLET This product has been designed to increase stiffness of insertion part of Olympus small intestinal…
Read the full statement (115 words)
XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE
This instrument has been designed to be used with the OLYMPUS EVIS Video System Center, EVIS Universal Light Source, Documentation Equipment, Video Monitor, Endo-Therapy Accessories (such as a Forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the small intestine.
XBO1-681-26 STYLET
This product has been designed to increase stiffness of insertion part of Olympus small intestinal videoscope XSIF-1TQ140A by inserting to the endoscope biopsy channel.
ST-S1 SPLINTING TUBE
This product has been designed to be used with the XSIF-1TQ140A for endoscopy within the small intestinal tract. This product is intended to facilitate insertion of the scope by straightening from the esophagus through stomach to descending part of 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/K031256 · printed Nov 4, 2026
Cite this page
510(k) Report. “K031256: Xsif-1TQ140A Small Intestinal Videoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K031256
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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