510(k) · Cleared
Recalled · Class II · 2024Autotome RX Model # 4515, 4516
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Oct 19, 2001 as substantially equivalent to K970053 (Boston Scientific Corp, 1997) after a 29-day review. Its family tree reaches back 1 generation to 1997. 43 later devices descend from it. It has been recalled 32 times.
- Decided
- Oct 19, 2001
- Review
- 29 days
- Class
- Class II
- Product code
- KNS
- Recalls
- 32
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970053 (1997). 43 later devices descend from it, 9 citing it directly.
- Root · 1 generation backK970053 UltratomerxBoston Scientific Corp · 1997
- This deviceK013153 Autotome RX Model # 4515, 4516Boston Scientific Corp · 2001
- Descendant · cites it directly · 29 of its ownK022595 Wilson-Cook CystotomeWilson-Cook Medical, Inc. · 2002
- Descendant · 2 generations on · 16 of its ownK092359 Echo Tip Ultra High Definition Ultrasound Access Needle, Model…Cook Ireland, Ltd. · 2009 · Recalled
- Descendant · 3 generations on · 11 of its ownK123676 Cellvizio 100 Series and Cellvizio Systems with Confocal MiniprobesMauna Kea Technologies · 2013
- Descendant · 4 generations on · 10 of its ownK132389 Cellvizio 100 Series System and Cellvizio System with Confocal…Daniel & Daniel Consulting · 2014
- Descendant · 5 generations on · 9 of its ownK141358 Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies · 2014
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · See all- K022595Wilson-Cook CystotomeWilson-Cook Medical, Inc. · 2002 · cites it directly29descendants
- K092359Echo Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-HD-19ACook Ireland, Ltd. · 2009 · 2 generations on16descendants
- K123676Cellvizio 100 Series and Cellvizio Systems with Confocal MiniprobesMauna Kea Technologies · 2013 · 3 generations on11descendants
- K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting · 2014 · 4 generations on10descendants
- K141358Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies · 2014 · 5 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970053 | Ultratomerx | Boston Scientific Corp | 1997 | — |
| 0 (this device) | K013153 | Autotome RX Model # 4515, 4516 | Boston Scientific Corp | 2001 | — |
| +1 | K022595 | Wilson-Cook Cystotome | Wilson-Cook Medical, Inc. | 2002 | — |
| +2 | K092359 | Echo Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-HD-19A | Cook Ireland, Ltd. | 2009 | 1 |
| +3 | K123676 | Cellvizio 100 Series and Cellvizio Systems with Confocal Miniprobes | Mauna Kea Technologies | 2013 | — |
| +4 | K132389 | Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes… | Daniel & Daniel Consulting | 2014 | — |
| +5 | K141358 | Cellvizio 100 Series with System Confocal Miniprobes | Mauna Kea Technologies | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K970053 | UltratomerxSummary page 1…me™ RX Sphincterotome Endoscope and Accessories Classified Under 21 CFR Part 876, §4300. Classified as a Class II Device. Rapid Exchange™ Cannulating Sphincterotome (K970053, Ultratome RX) The proposed Autotome™ RX is a triple lumen sphincterotome with controlled orientation and rotation features. It… | 1997 |
What descends from it? (43)
See all 439 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022595 | Wilson-Cook Cystotome | 2002 | 29 |
| K033203 | Wilson-Cook Tri-Tome Select Plus | 2003 | 6 |
| K232162 | Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44… | 2023 | 1 |
| K260962 | Sphincterotome | 2026 | 0 |
| K242192 | Disposable Sphincterotome | 2025 | 0 |
| K222421 | Sphincterotome | 2023 | 0 |
| K210934 | Sphincterotome / short-wire compatible, Sterile Sphincterotome | 2021 | 0 |
| K122203 | Truetome | 2012 | 0 |
| K061684 | Medi-Globe Rota-Cut Sphincterotome | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 12, 2024 | Class II | Z-2350-2024 | Process control | Foreign material may be present on the enclosed section of the cutting wire which may lead to inability to optimally bow the sphincterotome. This issue may lead to prolongation of procedure. |
| Dec 22, 2021 | Class II | Z-0753-2022 | Packaging process control | Sterility of device is compromised due to a sterile barrier breach |
| Dec 22, 2021 | Class II | Z-0761-2022 | Packaging process control | Sterility of device is compromised due to a sterile barrier breach |
| Dec 22, 2021 | Class II | Z-0770-2022 | Packaging process control | Sterility of device is compromised due to a sterile barrier breach |
| Dec 22, 2021 | Class II | Z-0772-2022 | Packaging process control | Sterility of device is compromised due to a sterile barrier breach |
| Dec 22, 2021 | Class II | Z-0775-2022 | Packaging process control | Sterility of device is compromised due to a sterile barrier breach |
| Dec 22, 2021 | Class II | Z-0779-2022 | Packaging process control | Sterility of device is compromised due to a sterile barrier breach |
| Dec 22, 2021 | Class II | Z-0780-2022 | Packaging process control | Sterility of device is compromised due to a sterile barrier breach |
| Dec 22, 2021 | Class II | Z-0781-2022 | Packaging process control | Sterility of device is compromised due to a sterile barrier breach |
| Dec 22, 2021 | Class II | Z-0751-2022 | Packaging process control | Sterility of device is compromised due to a sterile barrier breach |
| Dec 22, 2021 | Class II | Z-0752-2022 | Packaging process control | Sterility of device is compromised due to a sterile barrier breach |
| Dec 22, 2021 | Class II | Z-0758-2022 | Packaging process control | Sterility of device is compromised due to a sterile barrier breach |
| Dec 22, 2021 | Class II | Z-0762-2022 | Packaging process control | Sterility of device is compromised due to a sterile barrier breach |
| Dec 22, 2021 | Class II | Z-0763-2022 | Packaging process control | Sterility of device is compromised due to a sterile barrier breach |
| Dec 22, 2021 | Class II | Z-0766-2022 | Packaging process control | Sterility of device is compromised due to a sterile barrier breach |
| Dec 22, 2021 | Class II | Z-0768-2022 | Packaging process control | Sterility of device is compromised due to a sterile barrier breach |
| Dec 22, 2021 | Class II | Z-0776-2022 | Packaging process control | Sterility of device is compromised due to a sterile barrier breach |
| Dec 22, 2021 | Class II | Z-0777-2022 | Packaging process control | Sterility of device is compromised due to a sterile barrier breach |
| Dec 22, 2021 | Class II | Z-0778-2022 | Packaging process control | Sterility of device is compromised due to a sterile barrier breach |
| Dec 22, 2021 | Class II | Z-0769-2022 | Packaging process control | Sterility of device is compromised due to a sterile barrier breach |
| Dec 22, 2021 | Class II | Z-0774-2022 | Packaging process control | Sterility of device is compromised due to a sterile barrier breach |
| Dec 22, 2021 | Class II | Z-0754-2022 | Packaging process control | Sterility of device is compromised due to a sterile barrier breach |
| Dec 22, 2021 | Class II | Z-0755-2022 | Packaging process control | Sterility of device is compromised due to a sterile barrier breach |
| Dec 22, 2021 | Class II | Z-0756-2022 | Packaging process control | Sterility of device is compromised due to a sterile barrier breach |
| Dec 22, 2021 | Class II | Z-0757-2022 | Packaging process control | Sterility of device is compromised due to a sterile barrier breach |
| Dec 22, 2021 | Class II | Z-0759-2022 | Packaging process control | Sterility of device is compromised due to a sterile barrier breach |
| Dec 22, 2021 | Class II | Z-0760-2022 | Packaging process control | Sterility of device is compromised due to a sterile barrier breach |
| Dec 22, 2021 | Class II | Z-0764-2022 | Packaging process control | Sterility of device is compromised due to a sterile barrier breach |
| Dec 22, 2021 | Class II | Z-0765-2022 | Packaging process control | Sterility of device is compromised due to a sterile barrier breach |
| Dec 22, 2021 | Class II | Z-0767-2022 | Packaging process control | Sterility of device is compromised due to a sterile barrier breach |
| Dec 22, 2021 | Class II | Z-0771-2022 | Packaging process control | Sterility of device is compromised due to a sterile barrier breach |
| Dec 22, 2021 | Class II | Z-0773-2022 | Packaging process control | Sterility of device is compromised due to a sterile barrier breach |
The 5 latest of 32 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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?
The Autotome™ RX is indicated for use in transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The device can also be used to cannulate and inject contrast medium.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013153 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013153: Autotome RX Model # 4515, 4516.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013153
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026