510(k) · Cleared
Recalled · Class II · 2024AXIOS Stent and Delivery System, AXIOS 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 Mar 25, 2019 as substantially equivalent to K153088 (Boston Scientific Corporation, 2015) and 1 other predicate after a 252-day review. Its family tree reaches back 7 generations to 1997. 4 later devices descend from it. It has been recalled 8 times.
- Decided
- Mar 25, 2019
- Review
- 252 days
- Class
- Class II
- Product code
- PCU
- Recalls
- 8
- Predicates
- 2
Its longest line of descent runs back 7 generations to K970053 (1997). 11 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK970053 UltratomerxBoston Scientific Corp · 1997
- 6 generations backK013153 Autotome RX Model # 4515, 4516Boston Scientific Corp · 2001 · Recalled
- 5 generations backK022595 Wilson-Cook CystotomeWilson-Cook Medical, Inc. · 2002
- 4 generations backK150692 AXIOS Stent with Electrocautery Enhanced Delivery SystemBoston Scientific Corp · 2015
- 3 generations backK152572 AXIOS Stent and Delivery SystemBoston Scientific Corporation · 2015
- 2 generations backK153088 AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery…Boston Scientific Corporation · 2015
- 1 generation backK163272 AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation · 2017
- This deviceK181905 AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery…Boston Scientific Corporation · 2019
- Descendant · cites it directly · 2 of its ownK192043 AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation · 2019
- Descendant · cites it directly · 1 of its ownK220112 AXIOS Stent and Electrocautery-Enhanced Delivery SystemBoston Scientific Corporation · 2022
- Descendant · cites it directly · 1 of its ownK203132 AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation · 2021
- Descendant · 2 generations on · 0 of its ownK252648 Niti-S SPAXUS StentTaewoong Medical Co., Ltd. · 2026
Most influential descendants
Showing 4 of 4 · See all- K192043AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation · 2019 · cites it directly2descendants
- K220112AXIOS Stent and Electrocautery-Enhanced Delivery SystemBoston Scientific Corporation · 2022 · cites it directly1descendant
- K203132AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation · 2021 · cites it directly1descendant
- K252648Niti-S SPAXUS StentTaewoong Medical Co., Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K970053 | Ultratomerx | Boston Scientific Corp | 1997 | — |
| −6 | K013153 | Autotome RX Model # 4515, 4516 | Boston Scientific Corp | 2001 | 32 |
| −5 | K022595 | Wilson-Cook Cystotome | Wilson-Cook Medical, Inc. | 2002 | — |
| −4 | K150692 | AXIOS Stent with Electrocautery Enhanced Delivery System | Boston Scientific Corp | 2015 | — |
| −3 | 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 | — |
| −1 | K163272 | AXIOS Stent and Electrocautery Enhanced Delivery System | Boston Scientific Corporation | 2017 | — |
| 0 (this device) | K181905 | AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced… | Boston Scientific Corporation | 2019 | — |
| +1 | K192043 | AXIOS Stent and Electrocautery Enhanced Delivery System | Boston Scientific Corporation | 2019 | — |
| +1 | K220112 | AXIOS Stent and Electrocautery-Enhanced Delivery System | Boston Scientific Corporation | 2022 | — |
| +1 | K203132 | AXIOS Stent and Electrocautery Enhanced Delivery System | Boston Scientific Corporation | 2021 | — |
| +2 | 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 | 1 | 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 |
|---|---|---|---|
| * | K153088 | AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery…Summary page 5…ent and Electrocautery-Enhanced Delivery System & AXIOSTM Stent 510(k) Number: K153088/ K163272 Device Common Name: Pancreatic drainage stent and delivery system &… | 2015 |
| * | K163272 | AXIOS Stent and Electrocautery Enhanced Delivery SystemSummary page 5…lectrocautery-Enhanced Delivery System & AXIOSTM Stent 510(k) Number: K153088/ K163272 Device Common Name: Pancreatic drainage stent and delivery system &… | 2017 |
What descends from it? (4)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 20, 2024 | Class II | Z-1031-2025 | Process control | Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one. |
| Dec 20, 2024 | Class II | Z-1030-2025 | Process control | Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one. |
| Dec 1, 2020 | Class II | Z-0776-2021 | Process control | The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or procedure or risk of peritonitis… |
| Dec 1, 2020 | Class II | Z-0773-2021 | Process control | The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or procedure or risk of peritonitis… |
| Dec 1, 2020 | Class II | Z-0774-2021 | Process control | The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or procedure or risk of peritonitis… |
| Dec 1, 2020 | Class II | Z-0775-2021 | Process control | The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or procedure or risk of peritonitis… |
| Dec 1, 2020 | Class II | Z-0777-2021 | Process control | The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or procedure or risk of peritonitis… |
| Dec 1, 2020 | Class II | Z-0778-2021 | Process control | The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or procedure or risk of peritonitis… |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K192043 (Boston Scientific Corporation, 2019) has gone furthest, with 2 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. 2019, 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 & AXIOS Stent and Electrocautery Enhanced Delivery System are indicated for
use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts >6¢m in size,
and symptomatic Walled Off Necrosis >6¢m 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181905 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181905: AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced 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/K181905
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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