510(k) · Cleared
Recalled · 2003Zimmon Papillotome
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 Jun 18, 1990 after an 83-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it. It has been recalled once.
- Decided
- Jun 18, 1990
- Review
- 83 days
- Class
- Class II
- Product code
- KNS
- Recalls
- 1
- Predicates
- 0
11 later devices descend from it, 2 citing it directly.
- This deviceK901443 Zimmon PapillotomeWilson-Cook Medical, Inc. · 1990
- Descendant · cites it directly · 6 of its ownK033203 Wilson-Cook Tri-Tome Select PlusWilson-Cook Medical, Inc. · 2003
- Descendant · cites it directly · 4 of its ownK172665 Classic Cotton Cannulatome®, CannulaTome II® Double Lumen…Wilson-Cook Medical Inc./Cook Endoscopy · 2018
- Descendant · 2 generations on · 4 of its ownK052051 Omni SphincterotomeWilson-Cook Medical, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 3 of its ownK172288 Fusion OMNI SphincterotomeWilson-Cook Medical Inc./Cook Endoscopy · 2018
- Descendant · 2 generations on · 2 of its ownK201121 SphincterotomeHangzhou AGS MedTech Co., Ltd. · 2021
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K033203Wilson-Cook Tri-Tome Select PlusWilson-Cook Medical, Inc. · 2003 · cites it directly6descendants
- K172665Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton…Wilson-Cook Medical Inc./Cook Endoscopy · 2018 · cites it directly4descendants
- K052051Omni SphincterotomeWilson-Cook Medical, Inc. · 2005 · 2 generations on4descendants
- K172288Fusion OMNI SphincterotomeWilson-Cook Medical Inc./Cook Endoscopy · 2018 · 3 generations on3descendants
- K201121SphincterotomeHangzhou AGS MedTech Co., Ltd. · 2021 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K901443 | Zimmon Papillotome | Wilson-Cook Medical, Inc. | 1990 | — |
| +1 | K033203 | Wilson-Cook Tri-Tome Select Plus | Wilson-Cook Medical, Inc. | 2003 | — |
| +1 | K172665 | Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome… | Wilson-Cook Medical Inc./Cook Endoscopy | 2018 | — |
| +2 | K052051 | Omni Sphincterotome | Wilson-Cook Medical, Inc. | 2005 | 2 |
| +3 | K172288 | Fusion OMNI Sphincterotome | Wilson-Cook Medical Inc./Cook Endoscopy | 2018 | — |
| +2 | K201121 | Sphincterotome | Hangzhou AGS MedTech Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 112 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 |
|---|---|---|---|---|
| Dec 17, 2003 | Not classified | Z-0301-04 | Process control | Wire-Guided Sphinterotomes may be packaged with an incorrect wire guide label. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K033203 (Wilson-Cook Medical, Inc., 2003) has gone furthest, with 6 descendants of its own.
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 | — |
https://510kreport.com/device/K901443 · printed Nov 6, 2026
Cite this page
510(k) Report. “K901443: Zimmon Papillotome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K901443
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026