510(k) · Cleared
Recalled · Class II · 2026Single Use Preloaded Sphincterotome V (Distal Wireguided); Single Use SP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Copr. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Mar 31, 2015 as substantially equivalent to K122505 (Olympus Medical Systems Corp., 2013) after a 252-day review. Its family tree reaches back 5 generations to 1991. 4 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 31, 2015
- Review
- 252 days
- Class
- Class II
- Product code
- KNS
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 5 generations to K910722 (1991). 8 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK910722 450CM Guide Wire for G.I. UseTerumo Corp. · 1991
- 4 generations backK971937 Climber - Partially Coated Guide Wire for Endoscopic UseTerumo Medical Corp. · 1997
- 3 generations backK021179 Disposable Guidewire, Models G-205-3545S & G-205-3545AOlympus Optical Co., Ltd. · 2002
- 2 generations backK091417 Single Use Guidewire, Models G-240-2527S, G-240-2545S, G-240-2527A…Terumo Corp. · 2009
- 1 generation backK122505 Single Use Preloaded Sphincterotome VOlympus Medical Systems Corp. · 2013
- This deviceK141991 Single Use Preloaded Sphincterotome V (Distal Wireguided); Single…Olympus Medical Systems Copr. · 2015
- Descendant · cites it directly · 1 of its ownK192339 TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active CordWilson-Cook Medical, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK250945 Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600…Olympus Medical Systems Corp. · 2025 · Recalled
- Descendant · 2 generations on · 0 of its ownK243568 Teslatome Bipolar Sphincterotome; Tesla BiCord Active CordWilson-Cook Medical, Inc. · 2025 · Recalled
- Descendant · cites it directly · 0 of its ownK160241 Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215Olympus Medical Systems Corp. · 2016 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K192339TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active CordWilson-Cook Medical, Inc. · 2020 · cites it directly1descendant
- K250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use…Olympus Medical Systems Corp. · 2025 · cites it directly0descendants
- K243568Teslatome Bipolar Sphincterotome; Tesla BiCord Active CordWilson-Cook Medical, Inc. · 2025 · 2 generations on0descendants
- K160241Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215Olympus Medical Systems Corp. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K910722 | 450CM Guide Wire for G.I. Use | Terumo Corp. | 1991 | — |
| −4 | K971937 | Climber - Partially Coated Guide Wire for Endoscopic Use | Terumo Medical Corp. | 1997 | — |
| −3 | K021179 | Disposable Guidewire, Models G-205-3545S & G-205-3545A | Olympus Optical Co., Ltd. | 2002 | — |
| −2 | K091417 | Single Use Guidewire, Models G-240-2527S, G-240-2545S, G-240-2527A… | Terumo Corp. | 2009 | — |
| −1 | K122505 | Single Use Preloaded Sphincterotome V | Olympus Medical Systems Corp. | 2013 | — |
| 0 (this device) | K141991 | Single Use Preloaded Sphincterotome V (Distal Wireguided); Single Use SP | Olympus Medical Systems Copr. | 2015 | — |
| +1 | K192339 | TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord | Wilson-Cook Medical, Inc. | 2020 | — |
| +1 | K250945 | Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series)… | Olympus Medical Systems Corp. | 2025 | 16 |
| +2 | K243568 | Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord | Wilson-Cook Medical, Inc. | 2025 | 1 |
| +1 | K160241 | Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 | Olympus Medical Systems Corp. | 2016 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K122505 | Single Use Preloaded Sphincterotome VSummary page 5…se Sphincterotome V(Distal Wireguided) Model name Applicant 510(k) No. Single Use Preloaded OLYMPUS MEDICAL K122505 Sphincterotome V SYSTEMS CORP. IV. Device Description <Single Use Preloaded Sphincterotome V(Distal Wireguide… | 2013 |
| † | K091417 | Single Use Guidewire, Models G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A… | 2009 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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-1297-2026 | Process control | Devices which did not undergo thermoforming could deform and lose performance. |
| Jan 7, 2026 | Class II | Z-1278-2026 | Process control | Devices which did not undergo thermoforming could deform and lose performance. |
| Jan 7, 2026 | Class II | Z-1279-2026 | 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 24 years and passes through 5 companies; a new generation was cleared every 4.9 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K192339 (Wilson-Cook Medical, Inc., 2020) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K122505.
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. 2015, 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?
These instruments (sphincterotomes and guidewires) have been designed to be used with an Olympus endoscope for papillotomy using high-frequency current. 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.
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/K141991 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141991: Single Use Preloaded Sphincterotome V (Distal Wireguided); Single Use SP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141991
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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