510(k) · Cleared
ClearedSphincterotome
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hangzhou AGS MedTech Co., Ltd. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on May 3, 2023 as substantially equivalent to K013153 (Boston Scientific Corp, 2001) and 1 other predicate after a 265-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- May 3, 2023
- Review
- 265 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K972674 (1997). 7 ancestors in all, the oldest K901443 (1990). No later device cites it as a predicate yet.
- Root · 3 generations backK972674 Wilson-Cook Needle Knife PapillotomeWilson-Cook Medical, Inc. · 1997
- 2 generations backK040981 Usw Needleknife PapillotomeWilson-Cook Medical, Inc. · 2004
- 1 generation backK201121 SphincterotomeHangzhou AGS MedTech Co., Ltd. · 2021
- This deviceK222421 SphincterotomeHangzhou AGS MedTech Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K972674 | Wilson-Cook Needle Knife Papillotome | Wilson-Cook Medical, Inc. | 1997 | — |
| −2 | K040981 | Usw Needleknife Papillotome | Wilson-Cook Medical, Inc. | 2004 | — |
| −1 | K201121 | Sphincterotome | Hangzhou AGS MedTech Co., Ltd. | 2021 | — |
| 0 (this device) | K222421 | Sphincterotome | Hangzhou AGS MedTech Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 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 |
|---|---|---|---|
| * | K013153 | Autotome RX Model # 4515, 4516Summary page 4…rade Name: Autotome™ RX Device Name: Autotome RX Cannulating Sphincterotome Common Name: Sphincterotome 510(k) Number: K013153 Regulation class: Class II Regulation Number: 876.4300 Regulation Description: Endoscopic electrosurgical unit a… | 2001 |
| * | K201121 | SphincterotomeSummary page 5…ary Predicate Device Trade Name: Sphincterotome Device Name: Sphincterotome Common Name: Sphincterotome 510(k) Number: K201121 Regulation class: Class II Regulation Number: 876.4300 Regulation Description: Endoscopic electrosurgical unit a… | 2021 |
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 26 years and passes through 2 companies; a new generation was cleared every 6.7 years on median.
- 2 of the 7 ancestors have a recall of any class.
- 8 other devices also cite its predicate K013153.
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. 2023, 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?
The Sphincterotome is indicated for use in the cannulation of the biliary ducts and the transendoscopic sphincterotomy of the Papilla of Vater and/or the Spincter of Oddi. The device is supplied sterile and intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222421 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222421: Sphincterotome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222421
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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