510(k) · Decided
DecidedIntrastent LD (Large Diameter) Stent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sulzer Intratherapeutics, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Apr 16, 2002 as substantially equivalent to K991929 (Intratherapeutics, Inc., 1999) and 1 other predicate after a 56-day review. Its family tree reaches back 6 generations to 1991.
- Decided
- Apr 16, 2002
- Review
- 56 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K911292 (1991). 19 ancestors in all, the oldest K885180 (1989). No later device cites it as a predicate yet.
- Root · 6 generations backK911292 Schneider Wallstent (R)Pfizer Hospital Products Group, Inc. · 1991
- 5 generations backK961262 Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic…Boston Scientific Scimed, Inc. · 1996
- 4 generations backK964119 Wallstent Transhepatic Biliary EndoprosthesisBoston Scientific Scimed, Inc. · 1997 · Recalled
- 3 generations backK980653 Perflex Stainless Steel Stent and Delivery SystemCordis Corp. · 1998
- 2 generations backK991929 IntrastentIntratherapeutics, Inc. · 1999
- 1 generation backK993904 Intrastent Doublestrut LDIntratherapeutics, Inc. · 2000 · Recalled
- This deviceK020528 Intrastent LD (Large Diameter) StentSulzer Intratherapeutics, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K911292 | Schneider Wallstent (R) | Pfizer Hospital Products Group, Inc. | 1991 | — |
| −5 | K961262 | Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic Biliary… | Boston Scientific Scimed, Inc. | 1996 | — |
| −4 | K964119 | Wallstent Transhepatic Biliary Endoprosthesis | Boston Scientific Scimed, Inc. | 1997 | 6 |
| −3 | K980653 | Perflex Stainless Steel Stent and Delivery System | Cordis Corp. | 1998 | — |
| −2 | K991929 | Intrastent | Intratherapeutics, Inc. | 1999 | — |
| −1 | K993904 | Intrastent Doublestrut LD | Intratherapeutics, Inc. | 2000 | 1 |
| 0 (this device) | K020528 | Intrastent LD (Large Diameter) Stent | Sulzer Intratherapeutics, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 3 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 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? (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 |
|---|---|---|---|
| * | K991929 | IntrastentSummary page 1…e expanded state upon balloon deflation. Summary of technological characteristics: The IntraStent Mega and Max LD stents provide a larger version the IntraStent™ Stent (K991929), allowing expanded diameters of 9-12mm and 12mm. The IntraStent devices are balloon expandable stents fabricated by cutting an e… | 1999 |
| * | K993904 | Intrastent Doublestrut LDSummary page 2…edicate IntraStent™ Stent (K991929). The IntraStent is substantially equivalent* to the currently marketed IntraStent stent (K991929) and the IntraStent DoubleStrut LD (K993904) as a palliative treatment for malignant strictures of the biliary tree. As demonstrated, the modified IntraStent stent is identi… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
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 11 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 19 ancestors have a recall of any class.
- 2 other devices also cite its predicate K991929.
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 IntraStent® Mega™ LD (Large Diameter) Stent — Biliary Indication and the IntraStent® Max™ LD (Large Diameter) Stent — Biliary Indication are intended as a palliative treatment of malignant neoplasms in the biliary tree.
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/K020528 · printed Nov 4, 2026
Cite this page
510(k) Report. “K020528: Intrastent LD (Large Diameter) Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020528
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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