510(k) · Cleared
ClearedAutotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 39 Sphincterotome; Dreamtome Pro RX 44 Sphincterotome; Hydratome Pro RX 44 Sphincterotome; Jagtome Revolution Pro RX 39 Sphincterotome
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Aug 14, 2023 as substantially equivalent to K013153 (Boston Scientific Corp, 2001) after a 24-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- Aug 14, 2023
- Review
- 24 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K970053 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK970053 UltratomerxBoston Scientific Corp · 1997
- 1 generation backK013153 Autotome RX Model # 4515, 4516Boston Scientific Corp · 2001 · Recalled
- This deviceK232162 Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44…Boston Scientific Corporation · 2023
- Descendant · cites it directly · 0 of its ownK260962 SphincterotomeTaewoong Medical Co., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260962SphincterotomeTaewoong Medical Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970053 | Ultratomerx | Boston Scientific Corp | 1997 | — |
| −1 | K013153 | Autotome RX Model # 4515, 4516 | Boston Scientific Corp | 2001 | 32 |
| 0 (this device) | K232162 | Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome… | Boston Scientific Corporation | 2023 | — |
| +1 | K260962 | Sphincterotome | Taewoong Medical Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (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 |
|---|---|---|---|
| * | K013153 | Autotome RX Model # 4515, 4516Summary page 4…Gastroenterology/Urology Predicate Device Information: Trade Name: Autotome RX Sphincterotome 510(k) Number: K013153 Common Name: Sphincterotome Classification Name: Endoscopic electrosurgical unit and accessories… | 2001 |
| † | K122505 | Single Use Preloaded Sphincterotome V | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260962 | Sphincterotome | 2026 | 0 |
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 21.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K260962 (Taewoong Medical Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 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 Autotome Pro RX Sphincterotome is indicated for use in the selective cannulation of the Common Bile Ducts (CBD) and the transendoscopic sphincterotomy of the Papilla of Vater and/or Sphincter of Oddi. The Sphincterotome can also be used to inject contrast medium.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232162 · printed Nov 4, 2026
Cite this page
510(k) Report. “K232162: Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 39 Sphincterotome; Dreamtome Pro RX 44 Sphincterotome; Hydratome Pro RX 44 Sphincterotome; Jagtome Revolution Pro RX 39 Sphincterotome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K232162
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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