510(k) · Cleared
Recalled · Class II · 2026Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215
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 Mar 2, 2016 as substantially equivalent to K141991 (Olympus Medical Systems Copr., 2015) after a 30-day review. Its family tree reaches back 6 generations to 1991. It has been recalled once.
- Decided
- Mar 2, 2016
- Review
- 30 days
- Class
- Class II
- Product code
- KNS
- Recalls
- 1
- 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 deviceK160241 Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215Olympus Medical Systems Corp. · 2016
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) | K160241 | Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 | Olympus Medical Systems Corp. | 2016 | — |
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…otome V(Distal Wireguided) Model name Applicant 510(k) No. Single Use Sphincterotome V OLYMPUS MEDICAL K141991 SYSTEMS CORP. 5.4 Device Description The subject device consists of the papillotomy knife f… | 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-1282-2026 | Process control | Devices which did not undergo thermoforming could deform and lose performance. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 4.9 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. 2016, 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?
This instrument has been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160241 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160241: Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160241
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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