510(k) Report

510(k) · Decided

Decided

Modification to Intrastent

K992816510(k) SpecialDecided Oct 15, 199956-day reviewClass II21 CFR 876.5010

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Intratherapeutics, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts

Cleared on Oct 15, 1999 as substantially equivalent to K980290 (Intratherapeutics, Inc., 1998) and 5 other predicates after a 56-day review. Its family tree reaches back 5 generations to 1991.

Decided
Oct 15, 1999
Review
56 days
Class
Class II
Product code
FGE
Recalls
None
Predicates
6

Its longest line of descent runs back 5 generations to K911292 (1991). 18 ancestors in all, the oldest K885180 (1989). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 1 other ancestor1997: 2 other ancestors1991: 3 other ancestors1996: 1 other ancestor1994: 1 other ancestor1989: 3 other ancestors1992: 1 other ancestor1990: 1 other ancestorK911292 · Schneider Wallstent (R) · Pfizer Hospital Products Group, Inc. · 1991K961262 · Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic Biliary Endoprosthesis · Boston Scientific Scimed, Inc. · 1996K964119 · Wallstent Transhepatic Biliary Endoprosthesis · Boston Scientific Scimed, Inc. · 1997 · recalledK980653 · Perflex Stainless Steel Stent and Delivery System · Cordis Corp. · 1998K991929 · Intrastent · Intratherapeutics, Inc. · 19991985199019952000
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 6 other ancestors3 generations back: 3 other ancestors K991929 · Intrastent · Intratherapeutics, Inc. · 1999K980653 · Perflex Stainless Steel Stent and Delivery System · Cordis Corp. · 1998K964119 · Wallstent Transhepatic Biliary Endoprosthesis · Boston Scientific Scimed, Inc. · 1997 · recalledK961262 · Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic Biliary Endoprosthesis · Boston Scientific Scimed, Inc. · 1996K911292 · Schneider Wallstent (R) · Pfizer Hospital Products Group, Inc. · 1991−50
  1. Root · 5 generations backK911292 Schneider Wallstent (R)Pfizer Hospital Products Group, Inc. · 1991
  2. 4 generations backK961262 Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic…Boston Scientific Scimed, Inc. · 1996
  3. 3 generations backK964119 Wallstent Transhepatic Biliary EndoprosthesisBoston Scientific Scimed, Inc. · 1997 · Recalled
  4. 2 generations backK980653 Perflex Stainless Steel Stent and Delivery SystemCordis Corp. · 1998
  5. 1 generation backK991929 IntrastentIntratherapeutics, Inc. · 1999
  6. This deviceK992816 Modification to IntrastentIntratherapeutics, Inc. · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K911292Schneider Wallstent (R)Pfizer Hospital Products Group, Inc.1991—
−4K961262Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic Biliary…Boston Scientific Scimed, Inc.1996—
−3K964119Wallstent Transhepatic Biliary EndoprosthesisBoston Scientific Scimed, Inc.19976
−2K980653Perflex Stainless Steel Stent and Delivery SystemCordis Corp.1998—
−1K991929IntrastentIntratherapeutics, Inc.1999—
0 (this device)K992816Modification to IntrastentIntratherapeutics, Inc.1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198930
199010
199130
199210
199410
199610
199720
199810
FIG. 1 — Lineage of K992816, 1991–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K240464 WallFlex Biliary RX Stent System; Epic Biliary…score 14.5 · 13 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K980290Iti Stent
Summary page 1
…s 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, K980…
Intratherapeutics, Inc.199812
*K991929Intrastent
Summary page 1
…. Summary of technological characteristics: The modified IntraStent™ (models S12-12, S12-16, S12-26, S12-36, S12-56) provides a smaller version the ITI Stent (K980290 & K991929), allowing an expanded diameter of 4-7 mm. The IntraStent™ and predicate stents arc balloon expandable stents fabricated by cutti…
Intratherapeutics, Inc.1999—
*K905720Palmaz Biliary Stent
Summary page 1
…l 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 IntraStent™ is a balloon expandable stainless steel stent with an open lattice design. The devi…
Johnson & Johnson Interventional Systems1991—
*K911581Palmaz (TM) Balloon-Expandable Stent, Modification
Summary page 1
…ence* 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 IntraStent™ is a balloon expandable stainless steel stent with an open lattice design. The device is pro…
Johnson & Johnson Interventional Systems1991—
*K964688Long Medium Palmaz-Schatz Balloon Expandable Stent
Summary page 1
…claimed to IntraTherapeutics, Inc. ITI Stent (K980290) and Cordis Corporation PALMAZ™, & PALMAZ-SCHATZ™, and PERFLEX™ Balloon-Expandable Biliary Stent (K905720, K911581, K964688, K980653). The IntraStent™ is a balloon expandable stainless steel stent with an open lattice design. The device is provided unm…
Cordis Corp.1997—
*K980653Perflex Stainless Steel Stent and Delivery System
Summary page 1
…o IntraTherapeutics, Inc. ITI Stent (K980290) and Cordis Corporation PALMAZ™, & PALMAZ-SCHATZ™, and PERFLEX™ Balloon-Expandable Biliary Stent (K905720, K911581, K964688, K980653). The IntraStent™ is a balloon expandable stainless steel stent with an open lattice design. The device is provided unmounted, t…
Cordis Corp.1998—

Also cleared against K980290: 1 other device →

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 8 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
  • 2 of the 18 ancestors have a recall of any class.
  • 1 other device also cites its predicate K980290.

How does its category compare?

All FGE devices

FGE 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

2007: 42008: 112009: 72010: 92011: 92012: 82013: 52014: 82015: 82016: 42017: 92018: 72019: 22020: 42021: 12022: 62023: 62024: 62025: 72026 (partial year): 8
2007high 11 (2008) · low 1 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FGE

257in 2025

2007: 316 days median2008: 214 days median2009: 160 days median2010: 81 days median2011: 114 days median2012: 96 days median2013: 161 days median2014: 156 days median2015: 79 days median2016: 49 days median2017: 59 days median2018: 215 days median2020: 121 days median2022: 101 days median2023: 199 days median2024: 188 days median2025: 257 days median2026 (partial year): 153 days median
2007high 316 (2007) · low 49 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FGE

1in 2024

2007: 542008: 932009: 182010: 322011: 22012: 42013: 32017: 12018: 432019: 132020: 12021: 272022: 212023: 192024: 12026 (partial year): 11
2007high 93 (2008) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FGE

1,923in 2025

2007: 1,0062008: 1,4652009: 1,6552010: 1,4342011: 1,3212012: 1,1832013: 1,0602014: 1,2702015: 1,5432016: 1,4532017: 1,5152018: 1,6812019: 1,8962020: 2,1822021: 2,2972022: 1,7492023: 1,6152024: 1,9482025: 1,923
2007high 2,297 (2021) · low 1,006 (2007)2025

MAUDE reports naming product code FGE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074316541,006
200811214931,465
20097160181,655
2010981321,434
2011911421,321
201289641,183
2013516131,060
2014815601,270
201587901,543
201644901,453
201795911,515
20187215431,681
20192—131,896
2020412112,182
20211—272,297
20226101211,749
20236199191,615
2024618811,948
2025725701,923
2026815311—

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.

Also cleared against K980290

1 other device cites the same predicate.

  • K991929IntrastentIntratherapeutics, Inc. · 1999

More from Intratherapeutics, Inc.

15 FDA decisions under this applicant name. See the company

  • K011184Intrastent Doublestrut Paramount XS Biliary EndoprosthesisIntratherapeutics, Inc. · 2001
  • K003997Intrastent Doublestrut Paramount XS Biliary EndoprosthesisIntratherapeutics, Inc. · 2001
  • K003040Intrastent Protege Self-Expanding Nitinol Stent with Starport Delivery TechnologyIntratherapeutics, Inc. · 2000
  • K003450Intrastent Doublestrut Paramount Biliary EndoprosthesisIntratherapeutics, Inc. · 2000
  • K001648Intrastent Doublestrut ParamountIntratherapeutics, Inc. · 2000

Recent decisions in FGE

The FGE category page

  • K254179Drainage CatheterCanyon Medical, Inc. · 2026
  • K262913Protégé™ EverFlex™ Self-expanding Peripheral Stent SystemMedtronic, Inc. · 2026
  • K260835ARCHIMEDES Biodegradable Stent (Medium)Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) · 2026
  • K253393Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019…Hangzhou AGS MedTech Co., Ltd. · 2026
  • K253832Dilation Balloon CatheterMirco-Tech (Nanjing) Co., Ltd. · 2026

https://510kreport.com/device/K992816 · printed Nov 4, 2026

Cite this page

510(k) Report. “K992816: Modification to Intrastent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992816

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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