510(k) · Cleared
Recalled · Class II · 2026Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corp. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Oct 17, 2025 as substantially equivalent to K141991 (Olympus Medical Systems Copr., 2015) after a 203-day review. Its family tree reaches back 6 generations to 1991. It has been recalled 16 times.
- Decided
- Oct 17, 2025
- Review
- 203 days
- Class
- Class II
- Product code
- KNS
- Recalls
- 16
- Predicates
- 1
Its longest line of descent runs back 6 generations to K910722 (1991). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK910722 450CM Guide Wire for G.I. UseTerumo Corp. · 1991
- 5 generations backK971937 Climber - Partially Coated Guide Wire for Endoscopic UseTerumo Medical Corp. · 1997
- 4 generations backK021179 Disposable Guidewire, Models G-205-3545S & G-205-3545AOlympus Optical Co., Ltd. · 2002
- 3 generations backK091417 Single Use Guidewire, Models G-240-2527S, G-240-2545S, G-240-2527A…Terumo Corp. · 2009
- 2 generations backK122505 Single Use Preloaded Sphincterotome VOlympus Medical Systems Corp. · 2013
- 1 generation backK141991 Single Use Preloaded Sphincterotome V (Distal Wireguided); Single…Olympus Medical Systems Copr. · 2015 · Recalled
- This deviceK250945 Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600…Olympus Medical Systems Corp. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K910722 | 450CM Guide Wire for G.I. Use | Terumo Corp. | 1991 | — |
| −5 | K971937 | Climber - Partially Coated Guide Wire for Endoscopic Use | Terumo Medical Corp. | 1997 | — |
| −4 | K021179 | Disposable Guidewire, Models G-205-3545S & G-205-3545A | Olympus Optical Co., Ltd. | 2002 | — |
| −3 | K091417 | Single Use Guidewire, Models G-240-2527S, G-240-2545S, G-240-2527A… | Terumo Corp. | 2009 | — |
| −2 | K122505 | Single Use Preloaded Sphincterotome V | Olympus Medical Systems Corp. | 2013 | — |
| −1 | K141991 | Single Use Preloaded Sphincterotome V (Distal Wireguided); Single Use SP | Olympus Medical Systems Copr. | 2015 | 3 |
| 0 (this device) | K250945 | Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series)… | Olympus Medical Systems Corp. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 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 KNS? 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 KNS device
- #1 K241271 Aqua Medical RF Vapor Ablation Systemscore 17.2 · 20 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 |
|---|---|---|---|
| * | K141991 | Single Use Preloaded Sphincterotome V (Distal Wireguided); Single Use SPSummary page 5…r 876.4300 Product Code(s) KNS I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K141991 Single Use Sphincterotome V, Single Use Preloaded KNS Sphincterotome V (Distal Wireguided) Device Description Summary 21 CFR 807.… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 7, 2026 | Class II | Z-1284-2026 | Process control | Devices which did not undergo thermoforming could deform and lose performance. |
| Jan 7, 2026 | Class II | Z-1286-2026 | Process control | Devices which did not undergo thermoforming could deform and lose performance. |
| Jan 7, 2026 | Class II | Z-1280-2026 | Process control | Devices which did not undergo thermoforming could deform and lose performance. |
| Jan 7, 2026 | Class II | Z-1272-2026 | Process control | Devices which did not undergo thermoforming could deform and lose performance. |
| Jan 7, 2026 | Class II | Z-1271-2026 | Process control | Devices which did not undergo thermoforming could deform and lose performance. |
| Jan 7, 2026 | Class II | Z-1269-2026 | Process control | Devices which did not undergo thermoforming could deform and lose performance. |
| Jan 7, 2026 | Class II | Z-1283-2026 | Process control | Devices which did not undergo thermoforming could deform and lose performance. |
| Jan 7, 2026 | Class II | Z-1273-2026 | Process control | Devices which did not undergo thermoforming could deform and lose performance. |
| Jan 7, 2026 | Class II | Z-1274-2026 | Process control | Devices which did not undergo thermoforming could deform and lose performance. |
| Jan 7, 2026 | Class II | Z-1276-2026 | Process control | Devices which did not undergo thermoforming could deform and lose performance. |
| Jan 7, 2026 | Class II | Z-1270-2026 | Process control | Devices which did not undergo thermoforming could deform and lose performance. |
| Jan 7, 2026 | Class II | Z-1275-2026 | Process control | Devices which did not undergo thermoforming could deform and lose performance. |
| Jan 7, 2026 | Class II | Z-1277-2026 | Process control | Devices which did not undergo thermoforming could deform and lose performance. |
| Jan 7, 2026 | Class II | Z-1268-2026 | Process control | Devices which did not undergo thermoforming could deform and lose performance. |
| Jan 7, 2026 | Class II | Z-1281-2026 | Process control | Devices which did not undergo thermoforming could deform and lose performance. |
| Jan 7, 2026 | Class II | Z-1285-2026 | Process control | Devices which did not undergo thermoforming could deform and lose performance. |
The 5 latest of 16 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 34 years and passes through 5 companies; a new generation was cleared every 6.4 years on median.
- 2 of the 9 ancestors have a recall of any class.
- 2 other devices also cite its predicate K141991.
How does its category compare?
All KNS devicesKNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · KNS
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNS
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNS
14in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KNS
1,504in 2025
MAUDE reports naming product code KNS, 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 | 1 | — | 3 | 164 |
| 2008 | 3 | 61 | 5 | 587 |
| 2009 | 3 | 212 | 2 | 1,027 |
| 2010 | 4 | 168 | 0 | 908 |
| 2011 | 1 | — | 2 | 860 |
| 2012 | 2 | — | 0 | 848 |
| 2013 | 2 | — | 0 | 449 |
| 2014 | 1 | — | 0 | 405 |
| 2015 | 3 | 252 | 0 | 406 |
| 2016 | 3 | 30 | 6 | 457 |
| 2017 | 3 | 48 | 1 | 446 |
| 2018 | 5 | 62 | 0 | 563 |
| 2019 | 7 | 66 | 0 | 668 |
| 2020 | 4 | 212 | 0 | 906 |
| 2021 | 4 | 139 | 41 | 814 |
| 2022 | 3 | 182 | 0 | 913 |
| 2023 | 9 | 83 | 0 | 976 |
| 2024 | 3 | 198 | 14 | 1,533 |
| 2025 | 11 | 171 | 0 | 1,504 |
| 2026 | 2 | — | 4 | — |
What is it indicated for?
The Single Use Preloaded Sphincterotome V (Distal Wireguided) KD-VC631Q Series are intended to be used for papillotomy using high-frequency current in combination with an endoscope. The preloaded guidewire is used for guiding and exchanging endoscopic accessories for biliary duct, including but not limited to the common bile, cystic, pancreatic and right and left hepatic ducts. The Single Use Sphincterotome V (Distal Wireguided) KD-VC411Q/VC431Q/VC433Q…
Read the full statement (126 words)
The Single Use Preloaded Sphincterotome V (Distal Wireguided) KD-VC631Q Series are intended to be used for papillotomy using high-frequency current in combination with an endoscope. The preloaded guidewire is used for guiding and exchanging endoscopic accessories for biliary duct, including but not limited to the common bile, cystic, pancreatic and right and left hepatic ducts.
The Single Use Sphincterotome V (Distal Wireguided) KD-VC411Q/VC431Q/VC433Q Series are intended to be used for papillotomy using high-frequency current in combination with an endoscope.
The Single Use 3-Lumen Sphincterotome V KD-V411M/V431M Series is intended to be used for papillotomy using high-frequency current in combination with an endoscope and guidewire.
The DISPOSABLE TRIPLE LUMEN SPHINCTEROTOME KD-411Q/431Q Series is intended to be used for apillotomy using high-frequency current in combination with an endoscope.
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/K250945 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250945: Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250945
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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