510(k) · Decided

Decided

Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Model PC125BPS, PC126BPS, PC127BPS,PC128BPS, PC

K990631510(k) TraditionalDecided Apr 30, 199963-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

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

Cleared on Apr 30, 1999 as substantially equivalent to K905720 (Johnson & Johnson Interventional Systems, 1991) and 2 other predicates after a 63-day review. Its family tree reaches back 1 generation to 1991. 21 later devices descend from it.

Decided: Apr 30, 1999
Review: 63 days
Class: Class II
Product code: FGE
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K905720 (1991). 3 ancestors in all. 21 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK905720 Palmaz Biliary StentJohnson & Johnson Interventional Systems · 1991
This deviceK990631 Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery…Cordis Corp. · 1999
Descendant · cites it directly · 19 of its ownK991028 Cordis Palmaz Corinthian Transhepatic Biliary Stent and AccessoriesCordis Corp. · 1999
Descendant · cites it directly · 17 of its ownK992755 Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery…Cordis, A Johnson & Johnson Co. · 1999
Descendant · 2 generations on · 11 of its ownK994156 Modification to Cordis Palmaz Corinthian IQ Transhepatic Biliary…Cordis Corp. · 2000
Descendant · 2 generations on · 9 of its ownK012056 Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018…Cordis Europa, N.V. · 2001
Descendant · 2 generations on · 6 of its ownK012090 Cordis Palmaz Genesis Transhepatic Biliary StentCordis, A Johnson & Johnson Co. · 2001

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

1999high 4 (2001) · low 0 (2005)2026

Most influential descendants

Showing 5 of 21 · See all

K991028Cordis Palmaz Corinthian Transhepatic Biliary Stent and AccessoriesCordis Corp. · 1999 · cites it directly19descendants
K992755Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Cordis Crimping…Cordis, A Johnson & Johnson Co. · 1999 · cites it directly17descendants
K994156Modification to Cordis Palmaz Corinthian IQ Transhepatic Biliary Stent, Models PQ294B…Cordis Corp. · 2000 · 2 generations on11descendants
K012056Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery SystemCordis Europa, N.V. · 2001 · 2 generations on9descendants
K012090Cordis Palmaz Genesis Transhepatic Biliary StentCordis, A Johnson & Johnson Co. · 2001 · 2 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K905720	Palmaz Biliary Stent	Johnson & Johnson Interventional Systems	1991	—
0 (this device)	K990631	Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Model…	Cordis Corp.	1999	—
+1	K991028	Cordis Palmaz Corinthian Transhepatic Biliary Stent and Accessories	Cordis Corp.	1999	—
+1	K992755	Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery System…	Cordis, A Johnson & Johnson Co.	1999	—
+2	K994156	Modification to Cordis Palmaz Corinthian IQ Transhepatic Biliary Stent, Models…	Cordis Corp.	2000	—
+2	K012056	Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery System	Cordis Europa, N.V.	2001	—
+2	K012090	Cordis Palmaz Genesis Transhepatic Biliary Stent	Cordis, A Johnson & Johnson Co.	2001	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	3	0
2000	1	0
2001	4	0
2002	2	0
2003	4	0
2004	3	0
2006	1	0
2007	1	0
2010	1	0
2014	1	0

FIG. 1 — Lineage of K990631, 1991–2014Source: 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? (3)

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
*	K905720	Palmaz Biliary Stent Summary page 2 …orates the same method of deployment, materials, fundamental techpology and intended use as those found amotig predicate Cordis metal biliary stent products (see 510(k) #K905720, #K911581 and #K964688). The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System incorporates a modified sten…	Johnson & Johnson Interventional Systems	1991	—
*	K911581	Palmaz (TM) Balloon-Expandable Stent, Modification Summary page 1 …he Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System represents a line extension to the predicate Cordis PALMAZ Balloop-Expandable Stents (510(k) #K911581). Page 1 PALMAZ® CORINTHIANT Transhepatic Bifiary Steat and Delivery System K340 31 Cordis Corporation, 2 Johnso…	Johnson & Johnson Interventional Systems	1991	—
*	K964688	Long Medium Palmaz-Schatz Balloon Expandable Stent Summary page 1 …anshepatic Biliary Stent and Delivery System are substantially cquivalent to those featured among predecessor Cordis biliary stents (see 510(k) #K.905720, #K911561, and #K964688). In short, the Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System represents a line extension to the predi…	Cordis Corp.	1997	—

Also cleared against K905720: 9 other devices →

What descends from it? (21)

See all 21

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

Number	Device	Applicant	Decided	Descendants
K991028	Cordis Palmaz Corinthian Transhepatic Biliary Stent and Accessories	Cordis Corp.	1999	19
K992755	Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Cordis Crimping…	Cordis, A Johnson & Johnson Co.	1999	17
K991674	Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Models…	Cordis Corp.	1999	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?

None of the 3 ancestors has a recall.
Of its descendants, K991028 (Cordis Corp., 1999) has gone furthest, with 19 descendants of its own.
9 other devices also cite its predicate K905720.

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 Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System is indicated for the palliation of malignant neoplasms 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/K990631 · printed Nov 6, 2026

Cite this page

510(k) Report. “K990631: Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Model PC125BPS, PC126BPS, PC127BPS,PC128BPS, PC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990631

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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