510(k) · Decided
DecidedCordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Models PC155BJS, PCI156BJS, PC185BJS, PC186BJS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Corp. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Aug 12, 1999 as substantially equivalent to K990631 (Cordis Corp., 1999) after an 87-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Aug 12, 1999
- Review
- 87 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K905720 (1991). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK905720 Palmaz Biliary StentJohnson & Johnson Interventional Systems · 1991
- 1 generation backK990631 Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery…Cordis Corp. · 1999
- This deviceK991674 Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery…Cordis Corp. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K905720 | Palmaz Biliary Stent | Johnson & Johnson Interventional Systems | 1991 | — |
| −1 | K990631 | Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Model… | Cordis Corp. | 1999 | — |
| 0 (this device) | K991674 | Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery System… | Cordis Corp. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1997 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K990631 | Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Model PC125BPS…Summary page 1…nd Delivery System are substantially equivalent to those featured with the predicate Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System (see 510(k) #K990631). KINT4 p.2/3 PALMAZ® CORINTHIANTM Transhepatic Biliary Stent and Delivery System Cordis Corporation, a Johnson &… | 1999 |
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 8 years and passes through 2 companies; a new generation was cleared every 8.2 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K990631.
How does its category compare?
All FGE devicesFGE 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
2026 to Oct 25, outlined.
Median 510(k) review, days · FGE
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FGE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FGE
1,923in 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 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/K991674 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991674: Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Models PC155BJS, PCI156BJS, PC185BJS, PC186BJS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991674
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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