510(k) · Decided
DecidedDuramax .035 Biliary Stent System, Models DML0718-80, DML0718-135, DML0818-80, DML0818-135, DML0918-80, DML0918-135, DML
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avantec Vascular Corp. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Jul 9, 2003 after a 131-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Jul 9, 2003
- Review
- 131 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK030638 Duramax .035 Biliary Stent System, Models DML0718-80, DML0718-135…Avantec Vascular Corp. · 2003
- Descendant · cites it directly · 3 of its ownK033393 Absolute .035 Self-Expanding Biliary Stent SystemGuidant Corp. · 2003 · Recalled
- Descendant · 2 generations on · 1 of its ownK072720 Alimaxx-B Uncovered Biliary Stent SystemAlveolus, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 0 of its ownK093947 Alimaxx-B Uncovered Biliary Stent System EndoscopicMerit Medical Systems, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK072708 Absolute Pro .035 Self-Expanding Stent SystemAbbott Vascular-Vascular Solutions · 2008
Most influential descendants
Showing 4 of 4 · See all- K033393Absolute .035 Self-Expanding Biliary Stent SystemGuidant Corp. · 2003 · cites it directly3descendants
- K072720Alimaxx-B Uncovered Biliary Stent SystemAlveolus, Inc. · 2008 · 2 generations on1descendant
- K093947Alimaxx-B Uncovered Biliary Stent System EndoscopicMerit Medical Systems, Inc. · 2010 · 3 generations on0descendants
- K072708Absolute Pro .035 Self-Expanding Stent SystemAbbott Vascular-Vascular Solutions · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030638 | Duramax .035 Biliary Stent System, Models DML0718-80, DML0718-135, DML0818-80… | Avantec Vascular Corp. | 2003 | — |
| +1 | K033393 | Absolute .035 Self-Expanding Biliary Stent System | Guidant Corp. | 2003 | 5 |
| +2 | K072720 | Alimaxx-B Uncovered Biliary Stent System | Alveolus, Inc. | 2008 | 6 |
| +3 | K093947 | Alimaxx-B Uncovered Biliary Stent System Endoscopic | Merit Medical Systems, Inc. | 2010 | — |
| +2 | K072708 | Absolute Pro .035 Self-Expanding Stent System | Abbott Vascular-Vascular Solutions | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2008 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | — | Cordis PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035 Delivery System Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033393 | Absolute .035 Self-Expanding Biliary Stent System | 2003 | 3 |
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?
- Of its descendants, K033393 (Guidant Corp., 2003) has gone furthest, with 3 descendants of its own.
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.
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 DuraMaxTM.035 Biliary Stent System is indicated for palliation of malignant neoplasms in the biliary tree.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030638 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030638: Duramax .035 Biliary Stent System, Models DML0718-80, DML0718-135, DML0818-80, DML0818-135, DML0918-80, DML0918-135, DML.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030638
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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