510(k) · Decided

Decided

Dynalink .018 Billary Self-Expanding Stent System

K014007510(k) SpecialDecided Jan 7, 200233-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

Guidant Corp. · FGE Stents, Drains And Dilators For The Biliary Ducts

Cleared on Jan 7, 2002 as substantially equivalent to K002143 (Guidant Corp., 2000) after a 33-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.

Decided: Jan 7, 2002
Review: 33 days
Class: Class II
Product code: FGE
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K002143 (2000). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK002143 Dynalink Biliary Self-Expanding Stent SystemGuidant Corp. · 2000
This deviceK014007 Dynalink .018 Billary Self-Expanding Stent SystemGuidant Corp. · 2002
Descendant · cites it directly · 0 of its ownK021824 Dynalink .035 Biliary Self-Expanding Stent System, Models…Guidant Corp. · 2002

Most influential descendants

Showing 1 of 1 · See all

K021824Dynalink .035 Biliary Self-Expanding Stent System, Models…Guidant Corp. · 2002 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K002143	Dynalink Biliary Self-Expanding Stent System	Guidant Corp.	2000	—
0 (this device)	K014007	Dynalink .018 Billary Self-Expanding Stent System	Guidant Corp.	2002	—
+1	K021824	Dynalink .035 Biliary Self-Expanding Stent System, Models…	Guidant Corp.	2002	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0

FIG. 1 — Lineage of K014007, 2000–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K240464 WallFlex Biliary RX Stent System; Epic Biliary…score 14.5 · 13 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K002143	Dynalink Biliary Self-Expanding Stent System Summary page 1 …iliary Self-Expanding Stent System are substantially equivalent with regard to these features in the predicate device, the DYNALINK™ Biliary Self-Expanding Stent System (K002143, October 12, 2000). Device Description: The DYNALINK™ .018 Biliary Self-Expanding Stent System is a catheter designed to deploy…	Guidant Corp.	2000	—

Also cleared against K002143: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K021824	Dynalink .035 Biliary Self-Expanding Stent System, Models…	Guidant Corp.	2002	0

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?

Its one ancestor has no recall.
Of its descendants, K021824 (Guidant Corp., 2002) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K002143.

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

2007high 11 (2008) · low 1 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FGE

257in 2025

2007high 316 (2007) · low 49 (2016)2026

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

Recalls per year · FGE

1in 2024

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	4	316	54	1,006
2008	11	214	93	1,465
2009	7	160	18	1,655
2010	9	81	32	1,434
2011	9	114	2	1,321
2012	8	96	4	1,183
2013	5	161	3	1,060
2014	8	156	0	1,270
2015	8	79	0	1,543
2016	4	49	0	1,453
2017	9	59	1	1,515
2018	7	215	43	1,681
2019	2	—	13	1,896
2020	4	121	1	2,182
2021	1	—	27	2,297
2022	6	101	21	1,749
2023	6	199	19	1,615
2024	6	188	1	1,948
2025	7	257	0	1,923
2026	8	153	11	—

What is it indicated for?

The DYNALINK™ 018 Biliary Self-Expanding Stent System is indicated for the

palliation of malignant strictures 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.

https://510kreport.com/device/K014007 · printed Nov 6, 2026

Cite this page

510(k) Report. “K014007: Dynalink .018 Billary Self-Expanding 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/K014007

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026