510(k) · Decided
Recalled · 2010Alimaxx-B Uncovered Biliary Stent System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alveolus, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Apr 11, 2008 as substantially equivalent to K031186 (C.R. Bard, Inc., 2003) and 2 other predicates after a 199-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it. It has been recalled 6 times.
- Decided
- Apr 11, 2008
- Review
- 199 days
- Class
- Class II
- Product code
- FGE
- Recalls
- 6
- Predicates
- 3
Its longest line of descent runs back 4 generations to K002143 (2000). 16 ancestors in all, the oldest K971010 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK002143 Dynalink Biliary Self-Expanding Stent SystemGuidant Corp. · 2000
- 3 generations backK011881 Dynalink .035 Biliary Self-Expanding Stent SystemGuidant Corp. · 2001
- 2 generations backK014184 Modification to Dynalink .035 Biliary Self-Expanding Stent SystemGuidant Corp. · 2002
- 1 generation backK033393 Absolute .035 Self-Expanding Biliary Stent SystemGuidant Corp. · 2003 · Recalled
- This deviceK072720 Alimaxx-B Uncovered Biliary Stent SystemAlveolus, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK093947 Alimaxx-B Uncovered Biliary Stent System EndoscopicMerit Medical Systems, Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- K093947Alimaxx-B Uncovered Biliary Stent System EndoscopicMerit Medical Systems, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002143 | Dynalink Biliary Self-Expanding Stent System | Guidant Corp. | 2000 | — |
| −3 | K011881 | Dynalink .035 Biliary Self-Expanding Stent System | Guidant Corp. | 2001 | — |
| −2 | K014184 | Modification to Dynalink .035 Biliary Self-Expanding Stent System | Guidant Corp. | 2002 | — |
| −1 | K033393 | Absolute .035 Self-Expanding Biliary Stent System | Guidant Corp. | 2003 | 5 |
| 0 (this device) | K072720 | Alimaxx-B Uncovered Biliary Stent System | Alveolus, Inc. | 2008 | — |
| +1 | K093947 | Alimaxx-B Uncovered Biliary Stent System Endoscopic | Merit Medical Systems, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 FGE? 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 FGE device
- #1 K240464 WallFlex Biliary RX Stent System; Epic Biliary…score 14.5 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K031186 | Luminexx Endoscopic Biliary StentSummary page 1…stantially equivalent to previously cleared devices, including the Bard® LUMINEXX TM Biliary Stent and Delivery Catheter cleared by FDA under 510(k) number K031186, and the Cook® Zilver TM Biliary Stent cleared by FDA under 510(k) number K020788, and the AbsoluteTM Biliary, Self… | 2003 |
| * | K020788 | Wilson-Cook Zilver Biliary StentSummary page 1…TM Biliary Stent and Delivery Catheter cleared by FDA under 510(k) number K031186, and the Cook® Zilver TM Biliary Stent cleared by FDA under 510(k) number K020788, and the AbsoluteTM Biliary, Self-Expanding Stent cleared by FDA under 510(k) number K033393. Description… | 2002 |
| * | K033393 | Absolute .035 Self-Expanding Biliary Stent SystemSummary page 1…Zilver TM Biliary Stent cleared by FDA under 510(k) number K020788, and the AbsoluteTM Biliary, Self-Expanding Stent cleared by FDA under 510(k) number K033393. Description The ALIMAXX-B Uncovered biliary stent is a sterile, single-use, self- Alveolus ALIMAXX-B Uncovered… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093947 | Alimaxx-B Uncovered Biliary Stent System Endoscopic | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 28, 2010 | Not classified | Z-0803-2010 | Component change control | Degradation of the outer portion of the delivery catheter may prevent proper deployment of the biliary stent. |
| Jan 28, 2010 | Not classified | Z-0804-2010 | Component change control | Degradation of the outer portion of the delivery catheter may prevent proper deployment of the biliary stent. |
| Jan 28, 2010 | Not classified | Z-0806-2010 | Component change control | Degradation of the outer portion of the delivery catheter may prevent proper deployment of the biliary stent. |
| Jan 28, 2010 | Not classified | Z-0801-2010 | Component change control | Degradation of the outer portion of the delivery catheter may prevent proper deployment of the biliary stent. |
| Jan 28, 2010 | Not classified | Z-0802-2010 | Component change control | Degradation of the outer portion of the delivery catheter may prevent proper deployment of the biliary stent. |
| Jan 28, 2010 | Not classified | Z-0805-2010 | Component change control | Degradation of the outer portion of the delivery catheter may prevent proper deployment of the biliary stent. |
The 5 latest of 6 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 8 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- 5 of the 16 ancestors have a recall of any class.
- Of its descendants, K093947 (Merit Medical Systems, Inc., 2010) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K031186.
How does its category compare?
All FGE devicesFGE Stents, Drains And Dilators For The Biliary Ducts: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · FGE
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FGE
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FGE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FGE
1,923in 2025
MAUDE reports naming product code FGE, 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 | 4 | 316 | 54 | 1,006 |
| 2008 | 11 | 214 | 93 | 1,465 |
| 2009 | 7 | 160 | 18 | 1,655 |
| 2010 | 9 | 81 | 32 | 1,434 |
| 2011 | 9 | 114 | 2 | 1,321 |
| 2012 | 8 | 96 | 4 | 1,183 |
| 2013 | 5 | 161 | 3 | 1,060 |
| 2014 | 8 | 156 | 0 | 1,270 |
| 2015 | 8 | 79 | 0 | 1,543 |
| 2016 | 4 | 49 | 0 | 1,453 |
| 2017 | 9 | 59 | 1 | 1,515 |
| 2018 | 7 | 215 | 43 | 1,681 |
| 2019 | 2 | — | 13 | 1,896 |
| 2020 | 4 | 121 | 1 | 2,182 |
| 2021 | 1 | — | 27 | 2,297 |
| 2022 | 6 | 101 | 21 | 1,749 |
| 2023 | 6 | 199 | 19 | 1,615 |
| 2024 | 6 | 188 | 1 | 1,948 |
| 2025 | 7 | 257 | 0 | 1,923 |
| 2026 | 8 | 153 | 11 | — |
What is it indicated for?
The Alveolus, ALIMAXX-B Uncovered Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072720 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072720: Alimaxx-B Uncovered Biliary Stent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072720
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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