510(k) · Cleared
Recalled · 2009Omni Sphincterotome
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wilson-Cook Medical, Inc. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Aug 5, 2005 as substantially equivalent to K033203 (Wilson-Cook Medical, Inc., 2003) after a 7-day review. Its family tree reaches back 3 generations to 1997. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 5, 2005
- Review
- 7 days
- Class
- Class II
- Product code
- KNS
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to K970053 (1997). 4 ancestors in all, the oldest K901443 (1990). 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK970053 UltratomerxBoston Scientific Corp · 1997
- 2 generations backK013153 Autotome RX Model # 4515, 4516Boston Scientific Corp · 2001 · Recalled
- 1 generation backK033203 Wilson-Cook Tri-Tome Select PlusWilson-Cook Medical, Inc. · 2003
- This deviceK052051 Omni SphincterotomeWilson-Cook Medical, Inc. · 2005
- Descendant · cites it directly · 3 of its ownK172288 Fusion OMNI SphincterotomeWilson-Cook Medical Inc./Cook Endoscopy · 2018
- Descendant · 2 generations on · 1 of its ownK192339 TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active CordWilson-Cook Medical, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK251104 SureTome™ SW Sphincterotome with DomeTipWilson-Cook Medical · 2025
- Descendant · 3 generations on · 0 of its ownK243568 Teslatome Bipolar Sphincterotome; Tesla BiCord Active CordWilson-Cook Medical, Inc. · 2025 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K172288Fusion OMNI SphincterotomeWilson-Cook Medical Inc./Cook Endoscopy · 2018 · cites it directly3descendants
- K192339TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active CordWilson-Cook Medical, Inc. · 2020 · 2 generations on1descendant
- K251104SureTome™ SW Sphincterotome with DomeTipWilson-Cook Medical · 2025 · 2 generations on0descendants
- K243568Teslatome Bipolar Sphincterotome; Tesla BiCord Active CordWilson-Cook Medical, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970053 | Ultratomerx | Boston Scientific Corp | 1997 | — |
| −2 | K013153 | Autotome RX Model # 4515, 4516 | Boston Scientific Corp | 2001 | 32 |
| −1 | K033203 | Wilson-Cook Tri-Tome Select Plus | Wilson-Cook Medical, Inc. | 2003 | — |
| 0 (this device) | K052051 | Omni Sphincterotome | Wilson-Cook Medical, Inc. | 2005 | — |
| +1 | K172288 | Fusion OMNI Sphincterotome | Wilson-Cook Medical Inc./Cook Endoscopy | 2018 | — |
| +2 | K192339 | TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord | Wilson-Cook Medical, Inc. | 2020 | — |
| +2 | K251104 | SureTome™ SW Sphincterotome with DomeTip | Wilson-Cook Medical | 2025 | — |
| +3 | K243568 | Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord | Wilson-Cook Medical, Inc. | 2025 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K033203 | Wilson-Cook Tri-Tome Select PlusSummary page 1…21 CFR § 876.4300 PREDICATE DEVICES: Wilson-Cook Triple Tome Select Plus Sphincterotome (k033203) Wilson-Cook's OMNIlt Sphincterotome is INTENDED USE: intended for… | 2003 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172288 | Fusion OMNI Sphincterotome | 2018 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 12, 2009 | Not classified | Z-1598-2009 | Process control | The wire control port of these devices may be missing due to omission of a manufacturing activity. |
| Oct 30, 2008 | Not classified | Z-0325-2009 | Process control | The wire control port may have been omitted during manufacture. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K172288 (Wilson-Cook Medical Inc./Cook Endoscopy, 2018) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K033203.
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.
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?
Used for cannulation of the ductal system and sphincterotomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052051: Omni Sphincterotome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052051
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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