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 Feb 18, 2017 as substantially equivalent to K153088 (Boston Scientific Corporation, 2015) after an 89-day review. Its family tree reaches back 6 generations to 1997. 5 later devices descend from it.
- Decided
- Feb 18, 2017
- Review
- 89 days
- Class
- Class II
- Product code
- PCU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K970053 (1997). 10 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK970053 UltratomerxBoston Scientific Corp · 1997
- 5 generations backK013153 Autotome RX Model # 4515, 4516Boston Scientific Corp · 2001 · Recalled
- 4 generations backK022595 Wilson-Cook CystotomeWilson-Cook Medical, Inc. · 2002
- 3 generations backK150692 AXIOS Stent with Electrocautery Enhanced Delivery SystemBoston Scientific Corp · 2015
- 2 generations backK152572 AXIOS Stent and Delivery SystemBoston Scientific Corporation · 2015
- 1 generation backK153088 AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery…Boston Scientific Corporation · 2015
- This deviceK163272 AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation · 2017
- Descendant · cites it directly · 4 of its ownK181905 AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery…Boston Scientific Corporation · 2019 · Recalled
- Descendant · 2 generations on · 2 of its ownK192043 AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation · 2019
- Descendant · 2 generations on · 1 of its ownK220112 AXIOS Stent and Electrocautery-Enhanced Delivery SystemBoston Scientific Corporation · 2022
- Descendant · 2 generations on · 1 of its ownK203132 AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation · 2021
- Descendant · 3 generations on · 0 of its ownK252648 Niti-S SPAXUS StentTaewoong Medical Co., Ltd. · 2026
Most influential descendants
Showing 5 of 5 · See all- K181905AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation · 2019 · cites it directly4descendants
- K192043AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation · 2019 · 2 generations on2descendants
- K220112AXIOS Stent and Electrocautery-Enhanced Delivery SystemBoston Scientific Corporation · 2022 · 2 generations on1descendant
- K203132AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation · 2021 · 2 generations on1descendant
- K252648Niti-S SPAXUS StentTaewoong Medical Co., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K970053 | Ultratomerx | Boston Scientific Corp | 1997 | — |
| −5 | K013153 | Autotome RX Model # 4515, 4516 | Boston Scientific Corp | 2001 | 32 |
| −4 | K022595 | Wilson-Cook Cystotome | Wilson-Cook Medical, Inc. | 2002 | — |
| −3 | K150692 | AXIOS Stent with Electrocautery Enhanced Delivery System | Boston Scientific Corp | 2015 | — |
| −2 | 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 | — |
| 0 (this device) | K163272 | AXIOS Stent and Electrocautery Enhanced Delivery System | Boston Scientific Corporation | 2017 | — |
| +1 | K181905 | AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced… | Boston Scientific Corporation | 2019 | 8 |
| +2 | K192043 | AXIOS Stent and Electrocautery Enhanced Delivery System | Boston Scientific Corporation | 2019 | — |
| +2 | K220112 | AXIOS Stent and Electrocautery-Enhanced Delivery System | Boston Scientific Corporation | 2022 | — |
| +2 | K203132 | AXIOS Stent and Electrocautery Enhanced Delivery System | Boston Scientific Corporation | 2021 | — |
| +3 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K153088 | AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery…Summary page 4…AXIOSTM Stent and Electrocautery-Enhanced Delivery System 510(k) Number: K153088 Device Common Name: Pancreatic drainage stent and delivery system &… | 2015 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181905 | AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System | 2019 | 4 |
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 20 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K181905 (Boston Scientific Corporation, 2019) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K153088.
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. 2017, 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 ≥6cm in size, and symptomatic Walled Off Necrosis ≥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 or Walled Off Necrosis resolution.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163272 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163272: AXIOS Stent and Electrocautery Enhanced Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163272
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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