# K140561: Axios Stent and Delivery System (with 10MM X 10MM Stent) Axios Stent and Delivery System (with 15MM X 10MM Stent)

- Pathway: 510(k) (Special)
- Applicant: Xlumena, Inc.
- Decided: Apr 23, 2014 after 49 days
- Product code: PCU (Pancreatic Stent, Covered, Metallic, Removable)
- Device class: 2
- Regulation: 21 CFR 876.5015
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN130007 (2013). 1 ancestor in all.
9 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN130007: Axios Stent and Delivery System, Xlumena, Inc. (2013). 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.

## Most influential descendants
- K150692: AXIOS Stent with Electrocautery Enhanced Delivery System (2015), 8 descendants of its own
- K152572: AXIOS Stent and Delivery System (2015), 7 descendants of its own
- K153088: AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System (2015), 6 descendants of its own
- K163272: AXIOS Stent and Electrocautery Enhanced Delivery System (2017), 5 descendants of its own
- K181905: AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System (2019), 4 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K140561
Methodology: https://510kreport.com/methodology