510(k) · Cleared
ClearedAXIOS Stent and 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 Oct 6, 2015 as substantially equivalent to K140561 (Xlumena, Inc., 2014) and 1 other predicate after a 27-day review. Its family tree reaches back 4 generations to 1997. 7 later devices descend from it.
- Decided
- Oct 6, 2015
- Review
- 27 days
- Class
- Class II
- Product code
- PCU
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K970053 (1997). 8 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK970053 UltratomerxBoston Scientific Corp · 1997
- 3 generations backK013153 Autotome RX Model # 4515, 4516Boston Scientific Corp · 2001 · Recalled
- 2 generations backK022595 Wilson-Cook CystotomeWilson-Cook Medical, Inc. · 2002
- 1 generation backK150692 AXIOS Stent with Electrocautery Enhanced Delivery SystemBoston Scientific Corp · 2015
- This deviceK152572 AXIOS Stent and Delivery SystemBoston Scientific Corporation · 2015
- Descendant · cites it directly · 6 of its ownK153088 AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery…Boston Scientific Corporation · 2015
- Descendant · 2 generations on · 5 of its ownK163272 AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation · 2017
- Descendant · 2 generations on · 4 of its ownK181905 AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery…Boston Scientific Corporation · 2019 · Recalled
- Descendant · 3 generations on · 2 of its ownK192043 AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation · 2019
- Descendant · 3 generations on · 1 of its ownK220112 AXIOS Stent and Electrocautery-Enhanced Delivery SystemBoston Scientific Corporation · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K153088AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery…Boston Scientific Corporation · 2015 · cites it directly6descendants
- K163272AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation · 2017 · 2 generations on5descendants
- K181905AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation · 2019 · 2 generations on4descendants
- K192043AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation · 2019 · 3 generations on2descendants
- K220112AXIOS Stent and Electrocautery-Enhanced Delivery SystemBoston Scientific Corporation · 2022 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K970053 | Ultratomerx | Boston Scientific Corp | 1997 | — |
| −3 | K013153 | Autotome RX Model # 4515, 4516 | Boston Scientific Corp | 2001 | 32 |
| −2 | K022595 | Wilson-Cook Cystotome | Wilson-Cook Medical, Inc. | 2002 | — |
| −1 | K150692 | AXIOS Stent with Electrocautery Enhanced Delivery System | Boston Scientific Corp | 2015 | — |
| 0 (this device) | K152572 | AXIOS Stent and Delivery System | Boston Scientific Corporation | 2015 | — |
| +1 | K153088 | AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced… | Boston Scientific Corporation | 2015 | — |
| +2 | 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 |
| +3 | K192043 | AXIOS Stent and Electrocautery Enhanced Delivery System | Boston Scientific Corporation | 2019 | — |
| +3 | K220112 | AXIOS Stent and Electrocautery-Enhanced Delivery System | Boston Scientific Corporation | 2022 | — |
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 |
|---|---|---|
| 2015 | 1 | 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? (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 |
|---|---|---|---|
| * | K140561 | Axios Stent and Delivery System (with 10MM X 10MM Stent) Axios Stent and Delivery System…Summary page 4…rmation: Manufacturer Name of Predicate Device 510(k) # Clearance Date Boston Scientific* AXIOS Stent and Delivery System K140561 April 23, 2014 Boston Scientific* AXIOS Stent with Electrocautery K150692 August 8, 2015… | 2014 |
| * | K150692 | AXIOS Stent with Electrocautery Enhanced Delivery SystemSummary page 4…ce Date Boston Scientific* AXIOS Stent and Delivery System K140561 April 23, 2014 Boston Scientific* AXIOS Stent with Electrocautery K150692 August 8, 2015 Enhanced Delivery System *Manufacturer is now Boston Scientific Corporation thro… | 2015 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153088 | AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery… | 2015 | 6 |
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 18 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K153088 (Boston Scientific Corporation, 2015) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K140561.
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. 2015, 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 and Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 6 cm in size, with ≥ 70% fluid content that are adherent to the bowel wall. Once placed, the AXIOS Stent functions as a 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/K152572 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152572: AXIOS Stent and 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/K152572
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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