510(k) · Cleared
ClearedSmall Intestinal Videoscope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corporation · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Jun 28, 2005 as substantially equivalent to K001241 (The Olympus Optical Co., 2000) and 2 other predicates after a 15-day review. Its family tree reaches back 3 generations to 1986. 4 later devices descend from it.
- Decided
- Jun 28, 2005
- Review
- 15 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K853585 (1986). 8 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK853585 Olympus Evs-Endoscopic Video Image & Data SysOlympus Corp. · 1986 · Recalled
- 2 generations backK954451 Evis 140 SystemOlympus America, Inc. · 1996 · Recalled
- 1 generation backK031256 Xsif-1TQ140A Small Intestinal VideoscopeOlympus Opto-Electronics Co., Ltd. · 2003
- This deviceK051551 Small Intestinal Videoscope SystemOlympus Medical Systems Corporation · 2005
- Descendant · cites it directly · 3 of its ownK071254 Small Intestinal Videoscope SystemOlympus Medical Systems Corporation · 2008 · Recalled
- Descendant · 2 generations on · 1 of its ownK231323 Ancora-SBAspero Medical, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK260314 Ancora-SBAspero Medical, Inc. · 2026
- Descendant · 2 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 4 of 4 · See all- K071254Small Intestinal Videoscope SystemOlympus Medical Systems Corporation · 2008 · cites it directly3descendants
- K231323Ancora-SBAspero Medical, Inc. · 2023 · 2 generations on1descendant
- K260314Ancora-SBAspero Medical, Inc. · 2026 · 3 generations on0descendants
- K091759Single Use Splinting Tube, Models ST-Y0002-S, ST-Y0002-H, ST-Y0003-S and ST-Y0003-HOlympus Medical Systems Corporation · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K853585 | Olympus Evs-Endoscopic Video Image & Data Sys | Olympus Corp. | 1986 | 2 |
| −2 | K954451 | Evis 140 System | Olympus America, Inc. | 1996 | 3 |
| −1 | K031256 | Xsif-1TQ140A Small Intestinal Videoscope | Olympus Opto-Electronics Co., Ltd. | 2003 | — |
| 0 (this device) | K051551 | Small Intestinal Videoscope System | Olympus Medical Systems Corporation | 2005 | — |
| +1 | K071254 | Small Intestinal Videoscope System | Olympus Medical Systems Corporation | 2008 | 1 |
| +2 | K231323 | Ancora-SB | Aspero Medical, Inc. | 2023 | — |
| +3 | K260314 | Ancora-SB | Aspero Medical, Inc. | 2026 | — |
| +2 | 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 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 KNT? 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 KNT device
- #1 K261890 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®score 12.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K001241 | Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/ISummary page 2…e shows their regulatory histories. Model 510(k) # I Manufacturer Class Product Code PCF-160ALUI 1K001241 JOlympus Optical Co., LTD Il 78 FDF XSIF-1TQ140A K031256 Olympus Opt-electronics C… | 2000 |
| * | K031256 | Xsif-1TQ140A Small Intestinal VideoscopeSummary page 2…Class Product Code PCF-160ALUI 1K001241 JOlympus Optical Co., LTD Il 78 FDF XSIF-1TQ140A K031256 Olympus Opt-electronics Co., II 78 FDA,/ KOG Small Intestinal Videoscope LTD Fujinon Doub… | 2003 |
| * | K040048 | Fujinon Double Balloon Enteroscopy SystemSummary page 2…K031256 Olympus Opt-electronics Co., II 78 FDA,/ KOG Small Intestinal Videoscope LTD Fujinon Double Balloon K040048 Fujinon, Inc. II 78 FDA / KNT Enteroscopy System 4. Device Description The subject device,… | 2004 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071254 | Small Intestinal Videoscope System | 2008 | 3 |
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 19 years and passes through 4 companies; a new generation was cleared every 7.3 years on median.
- 3 of the 8 ancestors have a recall of any class.
- Of its descendants, K071254 (Olympus Medical Systems Corporation, 2008) has gone furthest, with 3 descendants of its own.
- 14 other devices also cite its predicate K001241.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNT
136in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNT
13in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KNT
1,451in 2025
MAUDE reports naming product code KNT, 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 | 10 | 118 | 1 | 300 |
| 2008 | 10 | 115 | 82 | 867 |
| 2009 | 11 | 102 | 9 | 818 |
| 2010 | 12 | 104 | 3 | 517 |
| 2011 | 7 | 211 | 2 | 531 |
| 2012 | 12 | 107 | 1 | 528 |
| 2013 | 7 | 128 | 0 | 747 |
| 2014 | 16 | 259 | 0 | 1,030 |
| 2015 | 10 | 140 | 1 | 1,048 |
| 2016 | 6 | 99 | 3 | 1,251 |
| 2017 | 9 | 247 | 4 | 1,672 |
| 2018 | 7 | 149 | 2 | 1,901 |
| 2019 | 10 | 126 | 2 | 1,838 |
| 2020 | 5 | 102 | 1 | 1,641 |
| 2021 | 6 | 121 | 2 | 1,655 |
| 2022 | 7 | 110 | 1 (1) | 1,650 |
| 2023 | 5 | 162 | 2 | 1,863 |
| 2024 | 9 | 103 | 0 | 1,344 |
| 2025 | 4 | 136 | 13 | 1,451 |
| 2026 | 3 | 105 | 20 | — |
What is it indicated for?
SMALL INTESTINAL VIDEOSCOPE SYSTEM
This system is composed of the small intestinal videoscope and the other ancillary equipment. The small intestinal scope has been designed to be used with the Olympus Video System Center, light source, endoscope balloon controller, splinting tube, balloons, documentation equipment, video monitor, electrosurgical unit, endo-therapy accessories such as biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within the upper and lower digestive tract including the esophagus, stomach, duodenum, small intestine and colon, by either oral or anal insertion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051551 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051551: Small Intestinal Videoscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051551
Report an extraction error
Are you the manufacturer?
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