510(k) · Cleared
ClearedSingle Use Splinting Tube, Models ST-Y0002-S, ST-Y0002-H, ST-Y0003-S and ST-Y0003-H
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 Sep 18, 2009 as substantially equivalent to K071254 (Olympus Medical Systems Corporation, 2008) after a 94-day review. Its family tree reaches back 5 generations to 1986.
- Decided
- Sep 18, 2009
- Review
- 94 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K853585 (1986). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK853585 Olympus Evs-Endoscopic Video Image & Data SysOlympus Corp. · 1986 · Recalled
- 4 generations backK954451 Evis 140 SystemOlympus America, Inc. · 1996 · Recalled
- 3 generations backK031256 Xsif-1TQ140A Small Intestinal VideoscopeOlympus Opto-Electronics Co., Ltd. · 2003
- 2 generations backK051551 Small Intestinal Videoscope SystemOlympus Medical Systems Corporation · 2005
- 1 generation backK071254 Small Intestinal Videoscope SystemOlympus Medical Systems Corporation · 2008 · Recalled
- This deviceK091759 Single Use Splinting Tube, Models ST-Y0002-S, ST-Y0002-H, ST-Y0003-S…Olympus Medical Systems Corporation · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K853585 | Olympus Evs-Endoscopic Video Image & Data Sys | Olympus Corp. | 1986 | 2 |
| −4 | K954451 | Evis 140 System | Olympus America, Inc. | 1996 | 3 |
| −3 | K031256 | Xsif-1TQ140A Small Intestinal Videoscope | Olympus Opto-Electronics Co., Ltd. | 2003 | — |
| −2 | K051551 | Small Intestinal Videoscope System | Olympus Medical Systems Corporation | 2005 | — |
| −1 | K071254 | Small Intestinal Videoscope System | Olympus Medical Systems Corporation | 2008 | 1 |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K071254 | Small Intestinal Videoscope SystemSummary page 3…ons Subject Device: Single Use Splinting Tube ST-Y0002-S, ST-Y0002-H, ST-Y0003-S, ST-Y0003-H Predicate Device: Single Use Splinting Tube ST-SB1 (K071254) Balloon Outer Diameter 4)25 mm d)40mm Length of Balloon 20mm… | 2008 |
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 23 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 4 of the 10 ancestors have a recall of any class.
- 1 other device also cites its predicate K071254.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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?
This instrument has been designed to be used with the VIDEOSCOPE XCHF-T160 for endoscopy and endoscopic surgery within the biliary tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091759 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091759: Single Use Splinting Tube, Models ST-Y0002-S, ST-Y0002-H, ST-Y0003-S and ST-Y0003-H.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091759
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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