510(k) · Cleared
ClearedAxios Stent and Delivery System (with 10MM X 10MM Stent) Axios Stent and Delivery System (with 15MM X 10MM Stent)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xlumena, Inc. · PCU Pancreatic Stent, Covered, Metallic, Removable
Cleared on Apr 23, 2014 as substantially equivalent to DEN130007 (Xlumena, Inc., 2013) after a 49-day review. Its family tree reaches back 1 generation to 2013. 9 later devices descend from it.
- Decided
- Apr 23, 2014
- Review
- 49 days
- Class
- Class II
- Product code
- PCU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN130007 (2013). 9 later devices descend from it, 2 citing it directly.
- Root · 1 generation backDEN130007 Axios Stent and Delivery SystemXlumena, Inc. · 2013
- This deviceK140561 Axios Stent and Delivery System (with 10MM X 10MM Stent) Axios Stent…Xlumena, Inc. · 2014
- Descendant · cites it directly · 8 of its ownK150692 AXIOS Stent with Electrocautery Enhanced Delivery SystemBoston Scientific Corp · 2015
- Descendant · cites it directly · 7 of its ownK152572 AXIOS Stent and Delivery SystemBoston Scientific Corporation · 2015
- Descendant · 2 generations on · 6 of its ownK153088 AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery…Boston Scientific Corporation · 2015
- Descendant · 3 generations on · 5 of its ownK163272 AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation · 2017
- Descendant · 3 generations on · 4 of its ownK181905 AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery…Boston Scientific Corporation · 2019 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K150692AXIOS Stent with Electrocautery Enhanced Delivery SystemBoston Scientific Corp · 2015 · cites it directly8descendants
- K152572AXIOS Stent and Delivery SystemBoston Scientific Corporation · 2015 · cites it directly7descendants
- K153088AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery…Boston Scientific Corporation · 2015 · 2 generations on6descendants
- K163272AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation · 2017 · 3 generations on5descendants
- K181905AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation · 2019 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN130007 | Axios Stent and Delivery System | Xlumena, Inc. | 2013 | — |
| 0 (this device) | K140561 | Axios Stent and Delivery System (with 10MM X 10MM Stent) Axios Stent and… | Xlumena, Inc. | 2014 | — |
| +1 | K150692 | AXIOS Stent with Electrocautery Enhanced Delivery System | Boston Scientific Corp | 2015 | — |
| +1 | K152572 | AXIOS Stent and Delivery System | Boston Scientific Corporation | 2015 | — |
| +2 | 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 | — |
| +3 | K181905 | AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced… | Boston Scientific Corporation | 2019 | 8 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 3 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 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
- #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 |
|---|---|---|---|
| * | DEN130007 | Axios Stent and Delivery System Our reading of the summary gave K123250, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN130007, Axios Stent and Delivery System (Xlumena, Inc.), granted Dec 18, 2013; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2013 |
What descends from it? (9)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2014, 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 Xlumena AXIOS Stent and Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 6cm in size, with ≥70% fluid content 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 resolution.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140561 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140561: Axios Stent and Delivery System (with 10MM X 10MM Stent) Axios Stent and Delivery System (with 15MM X 10MM Stent).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140561
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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