510(k) Report

510(k) · Decided

Recalled · 2004

Lifestent LP SDS Biliary Endoprosthesis

K023248510(k) TraditionalDecided Feb 11, 2003134-day reviewClass II21 CFR 876.5010Recalls 1

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

Orbus Medical Technologies · FGE Stents, Drains And Dilators For The Biliary Ducts

Cleared on Feb 11, 2003 after a 134-day review. The FDA summary names its predicate without a number. 54 later devices descend from it. It has been recalled once.

Decided
Feb 11, 2003
Review
134 days
Class
Class II
Product code
FGE
Recalls
1
Predicates
0

54 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2005: 5 descendants cleared2004: 1 descendant cleared2006: 1 descendant cleared2008: 1 descendant cleared2012: 3 descendants cleared2010: 1 descendant cleared2014: 2 descendants cleared2019: 2 descendants cleared2011: 1 descendant cleared2017: 3 descendants cleared2025: 4 descendants cleared2016: 2 descendants cleared2022: 5 descendants cleared2024: 7 descendants cleared2013: 2 descendants cleared2015: 3 descendants cleared2026: 4 descendants cleared2020: 3 descendants cleared2018: 2 descendants cleared2021: 2 descendants cleared200020052010201520202025
  1. This deviceK023248 Lifestent LP SDS Biliary EndoprosthesisOrbus Medical Technologies · 2003
  2. Descendant · cites it directly · 51 of its ownK041370 Lifestent LP SDS Biliary EndoprosthesisOrbus Medical Technologies · 2004
  3. Descendant · cites it directly · 50 of its ownK050627 Lifestent Turbo Biliary Stent SystemsEdwards Lifesciences, LLC · 2005
  4. Descendant · 2 generations on · 47 of its ownK052149 Edwards Peripheral Dilation CatheterEdwards Lifesciences, LLC · 2005
  5. Descendant · 3 generations on · 44 of its ownK083657 Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2008 · Recalled
  6. Descendant · 4 generations on · 36 of its ownK103459 Vascutrak Pta Dilatation CatheterC.R. Bard, Inc. · 2010

Showing 5 of 54 descendants. See all descendants

Descendants cleared per year

2004: 12005: 52006: 12008: 12010: 12011: 12012: 32013: 22014: 22015: 32016: 22017: 32018: 22019: 22020: 32021: 22022: 52024: 72025: 42026: 4
2004high 7 (2024) · low 0 (2007)2026

Most influential descendants

Showing 5 of 54 · See all
  • K041370Lifestent LP SDS Biliary EndoprosthesisOrbus Medical Technologies · 2004 · cites it directly51descendants
  • K050627Lifestent Turbo Biliary Stent SystemsEdwards Lifesciences, LLC · 2005 · cites it directly50descendants
  • K052149Edwards Peripheral Dilation CatheterEdwards Lifesciences, LLC · 2005 · 2 generations on47descendants
  • K083657Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2008 · 3 generations on44descendants
  • K103459Vascutrak Pta Dilatation CatheterC.R. Bard, Inc. · 2010 · 4 generations on36descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K023248Lifestent LP SDS Biliary EndoprosthesisOrbus Medical Technologies2003—
+1K041370Lifestent LP SDS Biliary EndoprosthesisOrbus Medical Technologies2004—
+1K050627Lifestent Turbo Biliary Stent SystemsEdwards Lifesciences, LLC2005—
+2K052149Edwards Peripheral Dilation CatheterEdwards Lifesciences, LLC2005—
+3K083657Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc.20082
+4K103459Vascutrak Pta Dilatation CatheterC.R. Bard, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200550
200610
200810
201010
201110
201230
201320
201420
201530
201620
201730
201820
201920
202030
202120
202250
202470
202540
202640
FIG. 1 — Lineage of K023248, 2003–2026Source: 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? (4)

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
*—IntraStent Doublestrut ParaMount XS Biliary Endoprosthesis
Named without a submission number
—
*—PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System
Named without a submission number
—
*—PALMAZ GENESIS Transhepatic Biliary Stent on SLALOM .018” Delivery System
Named without a submission number
—
*—OTW MEGALINK SDS Biliary Stent System
Named without a submission number
—

What descends from it? (54)

See all 54

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

NumberDeviceApplicantDecidedDescendants
K041370Lifestent LP SDS Biliary EndoprosthesisOrbus Medical Technologies200451
K050627Lifestent Turbo Biliary Stent SystemsEdwards Lifesciences, LLC200550
K051785Formula 418 Biliary StentCook, Inc.20051
K052539Cook Formula 418 Biliary Stent SystemCook, Inc.20050

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

Recalls of this device

DateClassRecallRoot causeReason
Mar 19, 2004Not classifiedZ-1075-04OtherBALLOONS HAVE LONGER THAN EXPECTED DEFLATION TIMES.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K041370 (Orbus Medical Technologies, 2004) has gone furthest, with 51 descendants of its own.

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 Orbus LifeStent LP SDS Biliary Endoprosthesis is indicated for use for the palliation of malignant neoplasms in the biliary tree.

Indications for use as stated in the FDA summary.

More from Orbus Medical Technologies

8 FDA decisions under this applicant name. See the company

  • K041370Lifestent LP SDS Biliary EndoprosthesisOrbus Medical Technologies · 2004
  • K041032Modification to Lifestent SDS and XL SDS Biliary EndoprosthesisOrbus Medical Technologies · 2004
  • K040550Lifestent SDS and XL SDS Biliary EndoprosthesisOrbus Medical Technologies · 2004
  • K033212Lifestent SDS Biliary EndoprosthesisOrbus Medical Technologies · 2003
  • K023308Lifestent SDS Biliary Endoprosthesis, Lifestent XL SDS Biliary EndoprosthesisOrbus Medical Technologies · 2003

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/K023248 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023248: Lifestent LP SDS Biliary Endoprosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023248

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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