510(k) · Cleared
ClearedSureTome™ SW Sphincterotome with DomeTip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wilson-Cook Medical · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Sep 29, 2025 as substantially equivalent to K172288 (Wilson-Cook Medical Inc./Cook Endoscopy, 2018) and 1 other predicate after a 171-day review. Its family tree reaches back 5 generations to 1997.
- Decided
- Sep 29, 2025
- Review
- 171 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K970053 (1997). 7 ancestors in all, the oldest K901443 (1990). No later device cites it as a predicate yet.
- Root · 5 generations backK970053 UltratomerxBoston Scientific Corp · 1997
- 4 generations backK013153 Autotome RX Model # 4515, 4516Boston Scientific Corp · 2001 · Recalled
- 3 generations backK033203 Wilson-Cook Tri-Tome Select PlusWilson-Cook Medical, Inc. · 2003
- 2 generations backK052051 Omni SphincterotomeWilson-Cook Medical, Inc. · 2005 · Recalled
- 1 generation backK172288 Fusion OMNI SphincterotomeWilson-Cook Medical Inc./Cook Endoscopy · 2018
- This deviceK251104 SureTome™ SW Sphincterotome with DomeTipWilson-Cook Medical · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K970053 | Ultratomerx | Boston Scientific Corp | 1997 | — |
| −4 | K013153 | Autotome RX Model # 4515, 4516 | Boston Scientific Corp | 2001 | 32 |
| −3 | K033203 | Wilson-Cook Tri-Tome Select Plus | Wilson-Cook Medical, Inc. | 2003 | — |
| −2 | K052051 | Omni Sphincterotome | Wilson-Cook Medical, Inc. | 2005 | 2 |
| −1 | K172288 | Fusion OMNI Sphincterotome | Wilson-Cook Medical Inc./Cook Endoscopy | 2018 | — |
| 0 (this device) | K251104 | SureTome™ SW Sphincterotome with DomeTip | Wilson-Cook Medical | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2018 | 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? (2)
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 |
|---|---|---|---|
| * | K172288 | Fusion OMNI SphincterotomeSummary page 5…KNS Device Class: Class II Classification Panel: Gastroenterology/Urology Predicate Device: Primary Predicate: Fusion OMNI Sphincterotome (K172288, Wilson-Cook Medical) cleared to market April 17, 2018. Reference Device: Tri-Tome pc Triple Lumen Sphincterotome (K172665, Wils… | 2018 |
| * | K172665 | Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton…Summary page 5…rimary Predicate: Fusion OMNI Sphincterotome (K172288, Wilson-Cook Medical) cleared to market April 17, 2018. Reference Device: Tri-Tome pc Triple Lumen Sphincterotome (K172665, Wilson-Cook Medical) cleared to market May 24, 2018. Device Description: The SureTome™ SW Sphincterotome with DomeTip ® are st… | 2018 |
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 28 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- 3 of the 7 ancestors have a recall of any class.
- 1 other device also cites its predicate K172288.
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?
This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251104 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251104: SureTome™ SW Sphincterotome with DomeTip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251104
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