510(k) Report

510(k) · Decided

Decided

5MM Protege Everflex Self Expanding Biliary Stent System, Model PRP35-05

K072301510(k) TraditionalDecided Mar 18, 2008214-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

Ev3, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts

Cleared on Mar 18, 2008 as substantially equivalent to K060057 (Ev3, Inc., 2006) and 4 other predicates after a 214-day review. Its family tree reaches back 3 generations to 1997. 2 later devices descend from it.

Decided
Mar 18, 2008
Review
214 days
Class
Class II
Product code
FGE
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to K964688 (1997). 9 ancestors in all. 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2003: 1 other ancestor2001: 1 other ancestor2000: 2 other ancestors1998: 1 other ancestor2012: 1 descendant cleared2026: 1 descendant clearedK964688 · Long Medium Palmaz-Schatz Balloon Expandable Stent · Cordis Corp. · 1997K030053 · Jostent Selfx, Models 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810 · Jomed AG · 2003K033537 · Selfx Xpert Biliary Stent, Models EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006, EX8L4006, EX8S2005, and EX8S3005 · Abbott Laboratories · 20031995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors3 generations back: 2 other ancestors 1 generation forward: 2 descendants K033537 · Selfx Xpert Biliary Stent, Models EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006, EX8L4006, EX8S2005, and EX8S3005 · Abbott Laboratories · 2003K030053 · Jostent Selfx, Models 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810 · Jomed AG · 2003K964688 · Long Medium Palmaz-Schatz Balloon Expandable Stent · Cordis Corp. · 19970
  1. Root · 3 generations backK964688 Long Medium Palmaz-Schatz Balloon Expandable StentCordis Corp. · 1997
  2. 2 generations backK030053 Jostent Selfx, Models 015SX4406; 015SX4408; 015SX4410; 015SX680…Jomed AG · 2003
  3. 1 generation backK033537 Selfx Xpert Biliary Stent, Models EX8L2005, EX8L3005, EX8L4005…Abbott Laboratories · 2003
  4. This deviceK072301 5MM Protege Everflex Self Expanding Biliary Stent System, Model…Ev3, Inc. · 2008
  5. Descendant · cites it directly · 0 of its ownK262913 Protégé™ EverFlex™ Self-expanding Peripheral Stent SystemMedtronic, Inc. · 2026
  6. Descendant · cites it directly · 0 of its ownK111627 Supera Veritas (R) Interwoven Self-Expanding Nitinol Stent…Idev Technologies, Inc. · 2012

Most influential descendants

Showing 2 of 2 · See all
  • K262913Protégé™ EverFlex™ Self-expanding Peripheral Stent SystemMedtronic, Inc. · 2026 · cites it directly0descendants
  • K111627Supera Veritas (R) Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemIdev Technologies, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K964688Long Medium Palmaz-Schatz Balloon Expandable StentCordis Corp.1997—
−2K030053Jostent Selfx, Models 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808…Jomed AG2003—
−1K033537Selfx Xpert Biliary Stent, Models EX8L2005, EX8L3005, EX8L4005, EX8L2006…Abbott Laboratories2003—
0 (this device)K0723015MM Protege Everflex Self Expanding Biliary Stent System, Model PRP35-05Ev3, Inc.2008—
+1K262913Protégé™ EverFlex™ Self-expanding Peripheral Stent SystemMedtronic, Inc.2026—
+1K111627Supera Veritas (R) Interwoven Self-Expanding Nitinol Stent Transhepatic…Idev Technologies, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200020
200110
200310
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
202610
FIG. 1 — Lineage of K072301, 1997–2026Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K060057Protege Everflex Self-Expanding Biliary Stent System
Summary page 1
…Biliary Catheter Class: Class II, 21 CFR 876.5010 Predicate Devices: Protegd® EverFleX'T Self-Expanding Biliary Stent System (K060057) Abbott Xpert" Self-Expanding Transhepatic Biliary Stent System (K033537)…
Ev3, Inc.20062
*K033537Selfx Xpert Biliary Stent, Models EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006…
Summary page 1
…1 CFR 876.5010 Predicate Devices: Protegd® EverFleX'T Self-Expanding Biliary Stent System (K060057) Abbott Xpert" Self-Expanding Transhepatic Biliary Stent System (K033537) Prot6g6® EverFlexT M System Traditional 510(k) Bard® LUMINEXXT " Bil…
Abbott Laboratories2003—
*K003793Bard Luminexx Biliary Stent
Summary page 2
…Stent System (K033537) Prot6g6® EverFlexT M System Traditional 510(k) Bard® LUMINEXXT " Biliary Stent System (K003793) Boston Scientific Sentinol TM (K032025) DYNALINK T Biliary Self-Expanding Stent System (K002143) This…
C.R. Bard, Inc.2001—
*K032025Sentinol Nitinol Billary Stent System
Summary page 2
…Prot6g6® EverFlexT M System Traditional 510(k) Bard® LUMINEXXT " Biliary Stent System (K003793) Boston Scientific Sentinol TM (K032025) DYNALINK T Biliary Self-Expanding Stent System (K002143) This summary is provided in compliance with se…
Boston Scientific Corp20031
*K002143Dynalink Biliary Self-Expanding Stent System
Summary page 2
…510(k) Bard® LUMINEXXT " Biliary Stent System (K003793) Boston Scientific Sentinol TM (K032025) DYNALINK T Biliary Self-Expanding Stent System (K002143) This summary is provided in compliance with section 513(J)(3)(A) of the Act and summarizes the safety and effectiveness informa…
Guidant Corp.2000—

Also cleared against K060057: 3 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K262913Protégé™ EverFlex™ Self-expanding Peripheral Stent SystemMedtronic, Inc.20260
K111627Supera Veritas (R) Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemIdev Technologies, Inc.20120

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 4 companies; a new generation was cleared every 4.3 years on median.
  • 2 of the 9 ancestors have a recall of any class.
  • Of its descendants, K262913 (Medtronic, Inc., 2026) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate K060057.

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. 2008, this device’s year, is highlighted.

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 Prot6gb® EverFlex' Self-Expanding Biliary Stent System is intended as a palliative treatment of malignant neoplasms in the biliary tree.

Indications for use as stated in the FDA summary.

Also cleared against K060057

3 other devices cite the same predicate.

  • K262913Protégé™ EverFlex™ Self-expanding Peripheral Stent SystemMedtronic, Inc. · 2026
  • K111627Supera Veritas (R) Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemIdev Technologies, Inc. · 2012
  • K062798Smart Nitinol Self-Expanding Stent, Model C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MBCordis Corp. · 20082 recalls

More from Ev3, Inc.

35 FDA decisions under this applicant name. See the company

  • K141118Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation CatheterEv3, Inc. · 20141 recall
  • K132777Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation CatheterEv3, Inc. · 2013
  • K130911Rapidcross Pta Rapid Exchange Balloon Dilatation CatheterEv3, Inc. · 2013
  • K123544Rapidcross Pta Rapid Exchange, Balloon Dilatation CatheterEv3, Inc. · 2013
  • K111723Turbohawk Peripheral Plaque Excision SystemEv3, Inc. · 20111 recall

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/K072301 · printed Nov 4, 2026

Cite this page

510(k) Report. “K072301: 5MM Protege Everflex Self Expanding Biliary Stent System, Model PRP35-05.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072301

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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