510(k) · Cleared
ClearedAXIOS Stent and Electrocautery-Enhanced Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · PCU Pancreatic Stent, Covered, Metallic, Removable
Cleared on Sep 7, 2022 as substantially equivalent to K181905 (Boston Scientific Corporation, 2019) and 1 other predicate after a 237-day review. Its family tree reaches back 9 generations to 1997. 1 later device descends from it.
- Decided
- Sep 7, 2022
- Review
- 237 days
- Class
- Class II
- Product code
- PCU
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K970053 (1997). 13 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK970053 UltratomerxBoston Scientific Corp · 1997
- 5 generations between
- 3 generations backK163272 AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation · 2017
- 2 generations backK181905 AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery…Boston Scientific Corporation · 2019 · Recalled
- 1 generation backK192043 AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation · 2019
- This deviceK220112 AXIOS Stent and Electrocautery-Enhanced Delivery SystemBoston Scientific Corporation · 2022
- Descendant · cites it directly · 0 of its ownK252648 Niti-S SPAXUS StentTaewoong Medical Co., Ltd. · 2026
Show all 9 generations
- Root · 9 generations backK970053 UltratomerxBoston Scientific Corp · 1997
- 8 generations backK013153 Autotome RX Model # 4515, 4516Boston Scientific Corp · 2001 · Recalled
- 7 generations backK022595 Wilson-Cook CystotomeWilson-Cook Medical, Inc. · 2002
- 6 generations backK150692 AXIOS Stent with Electrocautery Enhanced Delivery SystemBoston Scientific Corp · 2015
- 5 generations backK152572 AXIOS Stent and Delivery SystemBoston Scientific Corporation · 2015
- 4 generations backK153088 AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery…Boston Scientific Corporation · 2015
- 3 generations backK163272 AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation · 2017
- 2 generations backK181905 AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery…Boston Scientific Corporation · 2019 · Recalled
- 1 generation backK192043 AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation · 2019
- This deviceK220112 AXIOS Stent and Electrocautery-Enhanced Delivery SystemBoston Scientific Corporation · 2022
Most influential descendants
Showing 1 of 1 · See all- K252648Niti-S SPAXUS StentTaewoong 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 |
|---|---|---|---|---|---|
| −9 | K970053 | Ultratomerx | Boston Scientific Corp | 1997 | — |
| −8 | K013153 | Autotome RX Model # 4515, 4516 | Boston Scientific Corp | 2001 | 32 |
| −7 | K022595 | Wilson-Cook Cystotome | Wilson-Cook Medical, Inc. | 2002 | — |
| −6 | K150692 | AXIOS Stent with Electrocautery Enhanced Delivery System | Boston Scientific Corp | 2015 | — |
| −5 | K152572 | AXIOS Stent and Delivery System | Boston Scientific Corporation | 2015 | — |
| −4 | K153088 | AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced… | Boston Scientific Corporation | 2015 | — |
| −3 | K163272 | AXIOS Stent and Electrocautery Enhanced Delivery System | Boston Scientific Corporation | 2017 | — |
| −2 | K181905 | AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced… | Boston Scientific Corporation | 2019 | 8 |
| −1 | K192043 | AXIOS Stent and Electrocautery Enhanced Delivery System | Boston Scientific Corporation | 2019 | — |
| 0 (this device) | K220112 | AXIOS Stent and Electrocautery-Enhanced Delivery System | Boston Scientific Corporation | 2022 | — |
| +1 | K252648 | Niti-S SPAXUS Stent | Taewoong Medical Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
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 PCU? 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 PCU device
- #1 K252648 Niti-S SPAXUS Stentscore 13.7 · 10 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K181905 | AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery SystemSummary page 4…Electrocautery-Enhanced Delivery System 510(k) Numbers: K181905, K192043 Device Common Name: Pancreatic drainage stent and delivery system &… | 2019 |
| * | K192043 | AXIOS Stent and Electrocautery Enhanced Delivery SystemSummary page 4…utery-Enhanced Delivery System 510(k) Numbers: K181905, K192043 Device Common Name: Pancreatic drainage stent and delivery system &… | 2019 |
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 |
|---|---|---|---|
| K252648 | Niti-S SPAXUS Stent | 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 25 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K252648 (Taewoong Medical Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K181905.
How does its category compare?
All PCU devicesPCU Pancreatic Stent, Covered, Metallic, Removable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · PCU
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · PCU
46in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PCU
6in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PCU
292in 2025
MAUDE reports naming product code PCU, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 3 | 46 | 0 | 17 |
| 2016 | 0 | — | 0 | 101 |
| 2017 | 1 | — | 0 | 95 |
| 2018 | 0 | — | 0 | 90 |
| 2019 | 2 | — | 0 | 136 |
| 2020 | 0 | — | 6 | 144 |
| 2021 | 1 | — | 0 | 162 |
| 2022 | 1 | — | 0 | 208 |
| 2023 | 0 | — | 0 | 260 |
| 2024 | 0 | — | 0 | 416 |
| 2025 | 0 | — | 0 | 292 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The AXIOS™ Stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts > 6 cm in size, and symptomatic Walled Off Necrosis > 6 cm in size, that are adherent to the gastric or bowel wall. Once placed, the AXIOS™ Stent functions as an access port allowing passage of standard and therapeutic endoscopes to facilitate debridement, irrigation and cystoscopy. The Stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or Walled-Off Necrosis resolution.
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/K220112 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220112: AXIOS Stent and Electrocautery-Enhanced Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220112
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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