510(k) · Decided
DecidedIntrastent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intratherapeutics, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Aug 4, 1999 as substantially equivalent to K980290 (Intratherapeutics, Inc., 1998) and 4 other predicates after a 57-day review. Its family tree reaches back 4 generations to 1991. 3 later devices descend from it.
- Decided
- Aug 4, 1999
- Review
- 57 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K911292 (1991). 17 ancestors in all, the oldest K885180 (1989). 3 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK911292 Schneider Wallstent (R)Pfizer Hospital Products Group, Inc. · 1991
- 3 generations backK961262 Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic…Boston Scientific Scimed, Inc. · 1996
- 2 generations backK964119 Wallstent Transhepatic Biliary EndoprosthesisBoston Scientific Scimed, Inc. · 1997 · Recalled
- 1 generation backK980653 Perflex Stainless Steel Stent and Delivery SystemCordis Corp. · 1998
- This deviceK991929 IntrastentIntratherapeutics, Inc. · 1999
- Descendant · cites it directly · 1 of its ownK993904 Intrastent Doublestrut LDIntratherapeutics, Inc. · 2000 · Recalled
- Descendant · cites it directly · 0 of its ownK020528 Intrastent LD (Large Diameter) StentSulzer Intratherapeutics, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK992816 Modification to IntrastentIntratherapeutics, Inc. · 1999
Most influential descendants
Showing 3 of 3 · See all- K993904Intrastent Doublestrut LDIntratherapeutics, Inc. · 2000 · cites it directly1descendant
- K020528Intrastent LD (Large Diameter) StentSulzer Intratherapeutics, Inc. · 2002 · cites it directly0descendants
- K992816Modification to IntrastentIntratherapeutics, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K911292 | Schneider Wallstent (R) | Pfizer Hospital Products Group, Inc. | 1991 | — |
| −3 | K961262 | Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic Biliary… | Boston Scientific Scimed, Inc. | 1996 | — |
| −2 | K964119 | Wallstent Transhepatic Biliary Endoprosthesis | Boston Scientific Scimed, Inc. | 1997 | 6 |
| −1 | K980653 | Perflex Stainless Steel Stent and Delivery System | Cordis Corp. | 1998 | — |
| 0 (this device) | K991929 | Intrastent | Intratherapeutics, Inc. | 1999 | — |
| +1 | K993904 | Intrastent Doublestrut LD | Intratherapeutics, Inc. | 2000 | 1 |
| +1 | K020528 | Intrastent LD (Large Diameter) Stent | Sulzer Intratherapeutics, Inc. | 2002 | — |
| +1 | K992816 | Modification to Intrastent | Intratherapeutics, Inc. | 1999 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 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? (5)
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 |
|---|---|---|---|
| * | K980290 | Iti StentSummary page 1…is a Class II product classified under 21 CFR §8768.5010 as a biliary catheter and accessories. Substantial equivalence* is claimed to IntraTherapeutics, Inc. ITI Stent (K980290) and Cordis Corporation PALMAZ™, PALMAZ-SCHATZ™, and PERFLEX™ Balloon-Expandable Biliary Stent (K905720, K911581, K964688, K98065… | 1998 |
| * | K905720 | Palmaz Biliary StentSummary page 1…ial equivalence* is claimed to IntraTherapeutics, Inc. ITI Stent (K980290) and Cordis Corporation PALMAZ™, PALMAZ-SCHATZ™, and PERFLEX™ Balloon-Expandable Biliary Stent (K905720, K911581, K964688, K980653). The [ntraStent™ is a balloon expandable stainless steel stent with an open lattice design. The devi… | 1991 |
| * | K911581 | Palmaz (TM) Balloon-Expandable Stent, ModificationSummary page 1…alence* is claimed to IntraTherapeutics, Inc. ITI Stent (K980290) and Cordis Corporation PALMAZ™, PALMAZ-SCHATZ™, and PERFLEX™ Balloon-Expandable Biliary Stent (K905720, K911581, K964688, K980653). The [ntraStent™ is a balloon expandable stainless steel stent with an open lattice design. The device is pro… | 1991 |
| * | K964688 | Long Medium Palmaz-Schatz Balloon Expandable StentSummary page 1…s claimed to IntraTherapeutics, Inc. ITI Stent (K980290) and Cordis Corporation PALMAZ™, PALMAZ-SCHATZ™, and PERFLEX™ Balloon-Expandable Biliary Stent (K905720, K911581, K964688, K980653). The [ntraStent™ is a balloon expandable stainless steel stent with an open lattice design. The device is provided unm… | 1997 |
| * | K980653 | Perflex Stainless Steel Stent and Delivery SystemSummary page 1…to IntraTherapeutics, Inc. ITI Stent (K980290) and Cordis Corporation PALMAZ™, PALMAZ-SCHATZ™, and PERFLEX™ Balloon-Expandable Biliary Stent (K905720, K911581, K964688, K980653). The [ntraStent™ is a balloon expandable stainless steel stent with an open lattice design. The device is provided unmounted, t… | 1998 |
What descends from it? (3)
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)
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 8 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 17 ancestors have a recall of any class.
- Of its descendants, K993904 (Intratherapeutics, Inc., 2000) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K980290.
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™ Biliary Stent is indicated as a palliative treatment for 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/K991929 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991929: Intrastent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991929
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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