510(k) · Cleared

Cleared

Jostent Selfx, Models 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810

K030053510(k) TraditionalCleared Mar 31, 200398-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

Jomed AG · FGE Stents, Drains And Dilators For The Biliary Ducts

Cleared on Mar 31, 2003 as substantially equivalent to K002143 (Guidant Corp., 2000) and 3 other predicates after a 98-day review. Its family tree reaches back 1 generation to 1997. 8 later devices descend from it.

Decided: Mar 31, 2003
Review: 98 days
Class: Class II
Product code: FGE
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K964688 (1997). 4 ancestors in all. 8 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK964688 Long Medium Palmaz-Schatz Balloon Expandable StentCordis Corp. · 1997
This deviceK030053 Jostent Selfx, Models 015SX4406; 015SX4408; 015SX4410; 015SX680…Jomed AG · 2003
Descendant · cites it directly · 7 of its ownK033537 Selfx Xpert Biliary Stent, Models EX8L2005, EX8L3005, EX8L4005…Abbott Laboratories · 2003
Descendant · 2 generations on · 2 of its ownK072301 5MM Protege Everflex Self Expanding Biliary Stent System, Model…Ev3, Inc. · 2008
Descendant · 2 generations on · 1 of its ownK040667 Xpert Biliary Stent, Models EX8L6006, EX8L3008, EX8L4008, EX8L6008…Abbott Laboratories · 2004
Descendant · 2 generations on · 1 of its ownK033909 Wavemax Balloon-Expandable Transhepatic Biliary Stent SystemAbbott Laboratories · 2004
Descendant · 3 generations on · 0 of its ownK262913 Protégé™ EverFlex™ Self-expanding Peripheral Stent SystemMedtronic, Inc. · 2026

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2003high 3 (2004) · low 0 (2006)2026

Most influential descendants

Showing 5 of 8 · See all

K033537Selfx Xpert Biliary Stent, Models EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006…Abbott Laboratories · 2003 · cites it directly7descendants
K0723015MM Protege Everflex Self Expanding Biliary Stent System, Model PRP35-05Ev3, Inc. · 2008 · 2 generations on2descendants
K040667Xpert Biliary Stent, Models EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006, EX8S3008…Abbott Laboratories · 2004 · 2 generations on1descendant
K033909Wavemax Balloon-Expandable Transhepatic Biliary Stent SystemAbbott Laboratories · 2004 · 2 generations on1descendant
K262913Protégé™ EverFlex™ Self-expanding Peripheral Stent SystemMedtronic, Inc. · 2026 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K964688	Long Medium Palmaz-Schatz Balloon Expandable Stent	Cordis Corp.	1997	—
0 (this device)	K030053	Jostent Selfx, Models 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808…	Jomed AG	2003	—
+1	K033537	Selfx Xpert Biliary Stent, Models EX8L2005, EX8L3005, EX8L4005, EX8L2006…	Abbott Laboratories	2003	—
+2	K072301	5MM Protege Everflex Self Expanding Biliary Stent System, Model PRP35-05	Ev3, Inc.	2008	—
+2	K040667	Xpert Biliary Stent, Models EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006…	Abbott Laboratories	2004	—
+2	K033909	Wavemax Balloon-Expandable Transhepatic Biliary Stent System	Abbott Laboratories	2004	—
+3	K262913	Protégé™ EverFlex™ Self-expanding Peripheral Stent System	Medtronic, Inc.	2026	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2000	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	3	0
2005	1	0
2008	1	0
2012	1	0
2026	1	0

FIG. 1 — Lineage of K030053, 1997–2026Source: 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? (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.

Type	Number	Device	Applicant	Decided	Recalls
*	K002143	Dynalink Biliary Self-Expanding Stent System	Guidant Corp.	2000	—
*	K001222	Otw Megalink SDS Billiary Stent System, Models 1005509-18, 1005510-18, 1005511-18…	Guidant Corp.	2000	—
*	K983008	Peripheral Ave Stent System Summary page 1 …Guidant OTW MEGALINKTMSDS Biliary Stent System (KO0 1222) Peripheral AVE Biliary Stent System (K983008) Cordis Long Medium PALMAZ-SCHATZ Balloon Expandable Stent (K964688) Device De…	Peripheral Ave	1998	—
*	K964688	Long Medium Palmaz-Schatz Balloon Expandable Stent Summary page 1 …Peripheral AVE Biliary Stent System (K983008) Cordis Long Medium PALMAZ-SCHATZ Balloon Expandable Stent (K964688) Device Description: The JOSTENT SelfX Biliary Stent consists of a self-expanding Nitinol stent mounted on a catheter delivery…	Cordis Corp.	1997	—

Also cleared against K002143: 3 other devices →

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K033537	Selfx Xpert Biliary Stent, Models EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006…	Abbott Laboratories	2003	7

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?

None of the 4 ancestors has a recall.
Of its descendants, K033537 (Abbott Laboratories, 2003) has gone furthest, with 7 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 JOSTENT SelfX Biliary Stent is intended for use in the palliation of malignant strictues in the biliary tree.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030053 · printed Nov 5, 2026

Cite this page

510(k) Report. “K030053: Jostent Selfx, Models 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030053

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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