De Novo · Granted
GrantedAxios Stent and Delivery System
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
Granted on Dec 18, 2013 as a new device type through De Novo after a 302-day review. 10 later devices descend from it.
- Decided
- Dec 18, 2013
- Review
- 302 days
- Class
- Class II
- Product code
- PCU
- Recalls
- None
10 later devices descend from it, 2 citing it directly.
- This deviceDEN130007 Axios Stent and Delivery SystemXlumena, Inc. · 2013
- Descendant · cites it directly · 9 of its ownK140561 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 · 2 generations on · 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
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K140561Axios Stent and Delivery System (with 10MM X 10MM Stent) Axios Stent and Delivery System…Xlumena, Inc. · 2014 · cites it directly9descendants
- K150692AXIOS Stent with Electrocautery Enhanced Delivery SystemBoston Scientific Corp · 2015 · cites it directly8descendants
- K152572AXIOS Stent and Delivery SystemBoston Scientific Corporation · 2015 · 2 generations on7descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN130007 | Axios Stent and Delivery System | Xlumena, Inc. | 2013 | — |
| +1 | 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 | — |
| +2 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA De Novo database (decision fields), 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (10)
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?
- Of its descendants, K140561 (Xlumena, Inc., 2014) has gone furthest, with 9 descendants of its own.
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. 2013, 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 | — |
https://510kreport.com/device/DEN130007 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN130007: Axios Stent and Delivery System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN130007
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026