510(k) Report

510(k) · Cleared

Recalled · 2008

Iti Stent

K980290510(k) TraditionalCleared Jul 21, 1998176-day reviewClass II21 CFR 876.5010Recalls 12

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 Jul 21, 1998 as substantially equivalent to K905720 (Johnson & Johnson Interventional Systems, 1991) and 2 other predicates after a 176-day review. Its family tree reaches back 1 generation to 1991. 4 later devices descend from it. It has been recalled 12 times.

Decided
Jul 21, 1998
Review
176 days
Class
Class II
Product code
FGE
Recalls
12
Predicates
3

Its longest line of descent runs back 1 generation to K905720 (1991). 3 ancestors in all. 4 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor1991: 1 other ancestor1999: 2 descendants cleared2002: 1 descendant cleared2000: 1 descendant clearedK905720 · Palmaz Biliary Stent · Johnson & Johnson Interventional Systems · 19911990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 2 descendants K905720 · Palmaz Biliary Stent · Johnson & Johnson Interventional Systems · 19910
  1. Root · 1 generation backK905720 Palmaz Biliary StentJohnson & Johnson Interventional Systems · 1991
  2. This deviceK980290 Iti StentIntratherapeutics, Inc. · 1998
  3. Descendant · cites it directly · 3 of its ownK991929 IntrastentIntratherapeutics, Inc. · 1999
  4. Descendant · 2 generations on · 1 of its ownK993904 Intrastent Doublestrut LDIntratherapeutics, Inc. · 2000 · Recalled
  5. Descendant · 2 generations on · 0 of its ownK020528 Intrastent LD (Large Diameter) StentSulzer Intratherapeutics, Inc. · 2002
  6. Descendant · cites it directly · 0 of its ownK992816 Modification to IntrastentIntratherapeutics, Inc. · 1999

Most influential descendants

Showing 4 of 4 · See all
  • K991929IntrastentIntratherapeutics, Inc. · 1999 · cites it directly3descendants
  • K993904Intrastent Doublestrut LDIntratherapeutics, Inc. · 2000 · 2 generations on1descendant
  • K020528Intrastent LD (Large Diameter) StentSulzer Intratherapeutics, Inc. · 2002 · 2 generations on0descendants
  • K992816Modification to IntrastentIntratherapeutics, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K905720Palmaz Biliary StentJohnson & Johnson Interventional Systems1991—
0 (this device)K980290Iti StentIntratherapeutics, Inc.1998—
+1K991929IntrastentIntratherapeutics, Inc.1999—
+2K993904Intrastent Doublestrut LDIntratherapeutics, Inc.20001
+2K020528Intrastent LD (Large Diameter) StentSulzer Intratherapeutics, Inc.2002—
+1K992816Modification to IntrastentIntratherapeutics, Inc.1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199920
200010
200210
FIG. 1 — Lineage of K980290, 1991–2002Source: 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? (3)

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
*K905720Palmaz Biliary Stent
Summary page 1
…biliary catheter and accessories. Substantial equivalence is claimed to Cordis Corporation, legally marketed PALMAZ™ and PALMAZ-SCHATZ™ Balloon-Expandable Biliary Stent (K905720, K911581, K964688). IntraTherapeutics, Inc. device is a balloon expandable stainless steel stent with an open lattice design. Th…
Johnson & Johnson Interventional Systems1991—
*K911581Palmaz (TM) Balloon-Expandable Stent, Modification
Summary page 1
…atheter and accessories. Substantial equivalence is claimed to Cordis Corporation, legally marketed PALMAZ™ and PALMAZ-SCHATZ™ Balloon-Expandable Biliary Stent (K905720, K911581, K964688). IntraTherapeutics, Inc. device is a balloon expandable stainless steel stent with an open lattice design. The ITI Ste…
Johnson & Johnson Interventional Systems1991—
*K964688Long Medium Palmaz-Schatz Balloon Expandable Stent
Summary page 1
…nd accessories. Substantial equivalence is claimed to Cordis Corporation, legally marketed PALMAZ™ and PALMAZ-SCHATZ™ Balloon-Expandable Biliary Stent (K905720, K911581, K964688). IntraTherapeutics, Inc. device is a balloon expandable stainless steel stent with an open lattice design. The ITI Stent is pro…
Cordis Corp.1997—

Also cleared against K905720: 9 other devices →

What descends from it? (4)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K991929IntrastentIntratherapeutics, Inc.19993
K992816Modification to IntrastentIntratherapeutics, Inc.19990

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jan 18, 2008Not classifiedZ-1128-2008Labeling Change ControlIncorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.
Jan 18, 2008Not classifiedZ-1123-2008Labeling Change ControlIncorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.
Jan 18, 2008Not classifiedZ-1121-2008Labeling Change ControlIncorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.
Jan 18, 2008Not classifiedZ-1129-2008Labeling Change ControlIncorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.
Jan 18, 2008Not classifiedZ-1131-2008Labeling Change ControlIncorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.
Jan 18, 2008Not classifiedZ-1124-2008Labeling Change ControlIncorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.
Jan 18, 2008Not classifiedZ-1126-2008Labeling Change ControlIncorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.
Jan 18, 2008Not classifiedZ-1122-2008Labeling Change ControlIncorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.
Jan 18, 2008Not classifiedZ-1125-2008Labeling Change ControlIncorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.
Jan 18, 2008Not classifiedZ-1120-2008Labeling Change ControlIncorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.
Jan 18, 2008Not classifiedZ-1127-2008Labeling Change ControlIncorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.
Jan 18, 2008Not classifiedZ-1130-2008Labeling Change ControlIncorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.

The 5 latest of 12 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K991929 (Intratherapeutics, Inc., 1999) has gone furthest, with 3 descendants of its own.
  • 9 other devices also cite its predicate K905720.

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 ITI 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 K905720

9 other devices cite the same predicate.

  • K020809Modification to Cordis Palmaz Genesis Transhepatic Biliary StentCordis Corp. · 2002
  • K993904Intrastent Doublestrut LDIntratherapeutics, Inc. · 20001 recall
  • K992816Modification to IntrastentIntratherapeutics, Inc. · 1999
  • K991929IntrastentIntratherapeutics, Inc. · 1999
  • K991028Cordis Palmaz Corinthian Transhepatic Biliary Stent and AccessoriesCordis Corp. · 1999
  • K990631Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Model PC125BPS, PC126BPS…Cordis Corp. · 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

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  • 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/K980290 · printed Nov 4, 2026

Cite this page

510(k) Report. “K980290: Iti Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980290

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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