510(k) Report

510(k) · Cleared

Cleared

Cook Formula 418 Biliary Stent System

K052539510(k) SpecialCleared Dec 9, 200585-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

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

Cleared on Dec 9, 2005 as substantially equivalent to K051785 (Cook, Inc., 2005) and 3 other predicates after an 85-day review. Its family tree reaches back 4 generations to 1998.

Decided
Dec 9, 2005
Review
85 days
Class
Class II
Product code
FGE
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K983008 (1998). 8 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 1 other ancestor2002: 1 other ancestor2000: 1 other ancestor1999: 1 other ancestorK983008 · Peripheral Ave Stent System · Peripheral Ave · 1998K992569 · Medtronic Ave Bridge Stent · Medtronic Ave, Inc. · 1999K011817 · Bridge FX · Medtronic Ave, Inc. · 2001K051785 · Formula 418 Biliary Stent · Cook, Inc. · 2005199619982000200220042006
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors K051785 · Formula 418 Biliary Stent · Cook, Inc. · 2005K011817 · Bridge FX · Medtronic Ave, Inc. · 2001K992569 · Medtronic Ave Bridge Stent · Medtronic Ave, Inc. · 1999K983008 · Peripheral Ave Stent System · Peripheral Ave · 19980
  1. Root · 4 generations backK983008 Peripheral Ave Stent SystemPeripheral Ave · 1998
  2. 3 generations backK992569 Medtronic Ave Bridge StentMedtronic Ave, Inc. · 1999
  3. 2 generations backK011817 Bridge FXMedtronic Ave, Inc. · 2001
  4. 1 generation backK051785 Formula 418 Biliary StentCook, Inc. · 2005
  5. This deviceK052539 Cook Formula 418 Biliary Stent SystemCook, Inc. · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K983008Peripheral Ave Stent SystemPeripheral Ave1998—
−3K992569Medtronic Ave Bridge StentMedtronic Ave, Inc.1999—
−2K011817Bridge FXMedtronic Ave, Inc.2001—
−1K051785Formula 418 Biliary StentCook, Inc.2005—
0 (this device)K052539Cook Formula 418 Biliary Stent SystemCook, Inc.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200010
200210
200310
FIG. 1 — Lineage of K052539, 1998–2005Source: 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
*K051785Formula 418 Biliary Stent
Summary page 1
Cook® Formula 4 1 8 TM Biliary Stent System D.C. #K051785 39 Request for Additional Information 510(k) Summary…
Cook, Inc.2005—
*K011817Bridge FX
Summary page 1
…ant neoplasms in the Biliary tree. These devices include the Formula 418TM Biliary Stent System (D.C. #K051785), Bridge FX (Bridge Assurant) Stent Delivery System (D.C. #K01 1817) stent, the Palmaz Genesis Transhepatic Biliary Stent (D.C. #K021345) and the Lifestent LP SDS Biliary Endoprosthesis (D.C. #K023…
Medtronic Ave, Inc.2001—
*K021345Modification to Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery…
Summary page 1
…18TM Biliary Stent System (D.C. #K051785), Bridge FX (Bridge Assurant) Stent Delivery System (D.C. #K01 1817) stent, the Palmaz Genesis Transhepatic Biliary Stent (D.C. #K021345) and the Lifestent LP SDS Biliary Endoprosthesis (D.C. #K023248). Cook® Formula 418 T Biliary Stent System…
Cordis Corp.2002—
*K023248Lifestent LP SDS Biliary Endoprosthesis
Summary page 1
…urant) Stent Delivery System (D.C. #K01 1817) stent, the Palmaz Genesis Transhepatic Biliary Stent (D.C. #K021345) and the Lifestent LP SDS Biliary Endoprosthesis (D.C. #K023248). Cook® Formula 418 T Biliary Stent System M…
Orbus Medical Technologies20031

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 7 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
  • 1 of the 8 ancestors has a recall of any class.

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 Cook® Formula 418™ Biliary Stent System is indicated for use in palliation of malignant neoplasms in the biliary tree.

Indications for use as stated in the FDA summary.

More from Cook, Inc.

285 FDA decisions under this applicant name. See the company

  • P020018/S070Zenith Fenestrated AAA Endovascular Graft, Zenith Iliac BranchCook, Inc. · 2026
  • P020018/S069Zenith® Flex AAA Endovascular System; Zenith Fenestrated AAA Endovascular Graft (ZFEN); Zenith Iliac Branch…Cook, Inc. · 2026
  • P020018/S068Zenith (Flex) AAA Endovascular Graft; Zenith Renu AAA Ancillary Graft; Zenith Fenestrated AAA Endovascular…Cook, Inc. · 2026
  • P020018/S067Zenith Flex AAA Endovascular Graft Bifurcated Main Body; Zenith Renu AAA Ancillary Graft Converter; Zenith…Cook, Inc. · 2026
  • P020018/S066Zenith Flex AAA Endovascular System and Zenith Iliac BranchCook, Inc. · 2026

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/K052539 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052539: Cook Formula 418 Biliary Stent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052539

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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