510(k) · Decided
Recalled · 2006Absolute .035 Self-Expanding Biliary Stent System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guidant Corp. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Nov 10, 2003 as substantially equivalent to K014184 (Guidant Corp., 2002) and 4 other predicates after an 18-day review. Its family tree reaches back 3 generations to 2000. 3 later devices descend from it. It has been recalled 5 times.
- Decided
- Nov 10, 2003
- Review
- 18 days
- Class
- Class II
- Product code
- FGE
- Recalls
- 5
- Predicates
- 6
Its longest line of descent runs back 3 generations to K002143 (2000). 12 ancestors in all, the oldest K971010 (1997). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK002143 Dynalink Biliary Self-Expanding Stent SystemGuidant Corp. · 2000
- 2 generations backK011881 Dynalink .035 Biliary Self-Expanding Stent SystemGuidant Corp. · 2001
- 1 generation backK014184 Modification to Dynalink .035 Biliary Self-Expanding Stent SystemGuidant Corp. · 2002
- This deviceK033393 Absolute .035 Self-Expanding Biliary Stent SystemGuidant Corp. · 2003
- Descendant · cites it directly · 1 of its ownK072720 Alimaxx-B Uncovered Biliary Stent SystemAlveolus, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 0 of its ownK093947 Alimaxx-B Uncovered Biliary Stent System EndoscopicMerit Medical Systems, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK072708 Absolute Pro .035 Self-Expanding Stent SystemAbbott Vascular-Vascular Solutions · 2008
Most influential descendants
Showing 3 of 3 · See all- K072720Alimaxx-B Uncovered Biliary Stent SystemAlveolus, Inc. · 2008 · cites it directly1descendant
- K093947Alimaxx-B Uncovered Biliary Stent System EndoscopicMerit Medical Systems, Inc. · 2010 · 2 generations on0descendants
- K072708Absolute Pro .035 Self-Expanding Stent SystemAbbott Vascular-Vascular Solutions · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002143 | Dynalink Biliary Self-Expanding Stent System | Guidant Corp. | 2000 | — |
| −2 | K011881 | Dynalink .035 Biliary Self-Expanding Stent System | Guidant Corp. | 2001 | — |
| −1 | K014184 | Modification to Dynalink .035 Biliary Self-Expanding Stent System | Guidant Corp. | 2002 | — |
| 0 (this device) | K033393 | Absolute .035 Self-Expanding Biliary Stent System | Guidant Corp. | 2003 | — |
| +1 | K072720 | Alimaxx-B Uncovered Biliary Stent System | Alveolus, Inc. | 2008 | 6 |
| +2 | K093947 | Alimaxx-B Uncovered Biliary Stent System Endoscopic | Merit Medical Systems, Inc. | 2010 | — |
| +1 | K072708 | Absolute Pro .035 Self-Expanding Stent System | Abbott Vascular-Vascular Solutions | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (6)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K014184 | Modification to Dynalink .035 Biliary Self-Expanding Stent System | 2002 |
| Kept off the family tree | K020002 | FDA’s K020002 is Model P-33, Battery Operated, Three Wheel, Power Scooter , Model P-33 Our reading of the summary gave K020002, FDA’s number for Model P-33, Battery Operated, Three Wheel, Power Scooter… (Transworld Mobility Distribution, LLC). Its FDA name has none of the distinctive words the summary uses for the device it names, “SMART Therapeutics, Neuroform Microdelivery Stent System”. Kept off the family tree. Summary page 1…substantially equivalent to: 0 DYNALINKTM.035 Biliary Self-Expanding Stent System (KO14184) SMART Therapeutics, Neuroform Microdelivery StentSystem (H020002) 0 Cordis, SMART Control Nitinol Biliary Stent (K021898) 0 AngioDynamics AngioStent Biliary Stent System (K982346)… | 2002 |
| * | K021898 | Smart Control Nitinol Stent Transhepatic Biliary SystemSummary page 1…ry Self-Expanding Stent System (KO14184) SMART Therapeutics, Neuroform Microdelivery StentSystem (H020002) 0 Cordis, SMART Control Nitinol Biliary Stent (K021898) 0 AngioDynamics AngioStent Biliary Stent System (K982346) 0 Cordis, SMART Nitinol Stent (K020052) 0 Advante… | 2002 |
| * | K982346 | Angiodynamics Angiostent Biliary Stent SystemSummary page 1…ics, Neuroform Microdelivery StentSystem (H020002) 0 Cordis, SMART Control Nitinol Biliary Stent (K021898) 0 AngioDynamics AngioStent Biliary Stent System (K982346) 0 Cordis, SMART Nitinol Stent (K020052) 0 Advantec Vascular, DuraMax Biliary Stent System (K030638) Device Des… | 1999 |
| * | K020052 | Smart Nitinol Stent Transhepatic Biliary SystemSummary page 1…02) 0 Cordis, SMART Control Nitinol Biliary Stent (K021898) 0 AngioDynamics AngioStent Biliary Stent System (K982346) 0 Cordis, SMART Nitinol Stent (K020052) 0 Advantec Vascular, DuraMax Biliary Stent System (K030638) Device Description: The ABSOLUTETMBiliary Self-Expand… | 2002 |
| * | K030638 | Duramax .035 Biliary Stent System, Models DML0718-80, DML0718-135, DML0818-80…Summary page 1…0 AngioDynamics AngioStent Biliary Stent System (K982346) 0 Cordis, SMART Nitinol Stent (K020052) 0 Advantec Vascular, DuraMax Biliary Stent System (K030638) Device Description: The ABSOLUTETMBiliary Self-Expanding Stent System is comprised of the ABSOLUTETMstent pre-mounted… | 2003 |
What descends from it? (3)
2 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 |
|---|---|---|---|---|
| Mar 22, 2006 | Not classified | Z-1082-06 | Other | Design : increasing number of customer complaints with a trend of stent deployment difficulties. The difficulties are reported during acute deployment of the stent, therefore patients in whom a stent has successfully been implanted are… |
| Mar 22, 2006 | Not classified | Z-1080-06 | Other | Design : increasing number of customer complaints with a trend of stent deployment difficulties. The difficulties are reported during acute deployment of the stent, therefore patients in whom a stent has successfully been implanted are… |
| Mar 22, 2006 | Not classified | Z-1084-06 | Other | Design : increasing number of customer complaints with a trend of stent deployment difficulties. The difficulties are reported during acute deployment of the stent, therefore patients in whom a stent has successfully been implanted are… |
| Mar 22, 2006 | Not classified | Z-1083-06 | Other | Design : increasing number of customer complaints with a trend of stent deployment difficulties. The difficulties are reported during acute deployment of the stent, therefore patients in whom a stent has successfully been implanted are… |
| Mar 22, 2006 | Not classified | Z-1085-06 | Other | Design : increasing number of customer complaints with a trend of stent deployment difficulties. The difficulties are reported during acute deployment of the stent, therefore patients in whom a stent has successfully been implanted are… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 9 months on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K072720 (Alveolus, Inc., 2008) has gone furthest, with 1 descendant 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 ABSOLUTE.035 Biliary Self Expanding Stent is intended for palliation of malignant strictures in the biliary tree.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033393 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033393: Absolute .035 Self-Expanding 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/K033393
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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