510(k) · Decided
Recalled · 2004Precise RX Nitinol Stent Transhepatic Biliary System
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 Sep 17, 2003 as substantially equivalent to K012993 (Cordis Corp., 2001) and 4 other predicates after a 68-day review. Its family tree reaches back 5 generations to 1991. It has been recalled once.
- Decided
- Sep 17, 2003
- Review
- 68 days
- Class
- Class II
- Product code
- FGE
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 5 generations to K911292 (1991). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK911292 Schneider Wallstent (R)Pfizer Hospital Products Group, Inc. · 1991
- 4 generations backK961262 Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic…Boston Scientific Scimed, Inc. · 1996
- 3 generations backK964119 Wallstent Transhepatic Biliary EndoprosthesisBoston Scientific Scimed, Inc. · 1997 · Recalled
- 2 generations backK993232 Wallstent Biliary Endoprosthesis and Unistep Plus Delivery SystemBoston Scientific Scimed, Inc. · 1999
- 1 generation backK012822 Modificiation to: Biliary Wallstent Endoprostheis with Monorail…Boston Scientific Scimed, Inc. · 2001
- This deviceK032137 Precise RX Nitinol Stent Transhepatic Biliary SystemCordis Corp. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K911292 | Schneider Wallstent (R) | Pfizer Hospital Products Group, Inc. | 1991 | — |
| −4 | K961262 | Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic Biliary… | Boston Scientific Scimed, Inc. | 1996 | — |
| −3 | K964119 | Wallstent Transhepatic Biliary Endoprosthesis | Boston Scientific Scimed, Inc. | 1997 | 6 |
| −2 | K993232 | Wallstent Biliary Endoprosthesis and Unistep Plus Delivery System | Boston Scientific Scimed, Inc. | 1999 | — |
| −1 | K012822 | Modificiation to: Biliary Wallstent Endoprostheis with Monorail Delivery… | Boston Scientific Scimed, Inc. | 2001 | — |
| 0 (this device) | K032137 | Precise RX Nitinol Stent Transhepatic Biliary System | Cordis Corp. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K012993 | Modification to Precise Nitinol Stent Transhepatic Biliary System | 2001 |
| * | K010445 | Precise Nitinol Stent Transhepatic Billary System | 2001 |
| * | K021898 | Smart Control Nitinol Stent Transhepatic Biliary System | 2002 |
| * | K012822 | Modificiation to: Biliary Wallstent Endoprostheis with Monorail Delivery System, Model… | 2001 |
| * | K020682 | Bard Luminexx 6 FR Biliary Stent and Delivery System | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 13, 2004 | Not classified | Z-0909-04 | Other | Air may be introduced into this Stent system when used with certain size acessory devices. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 14 ancestors have a recall of any class.
- 2 other devices also cite its predicate K012993.
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 Precise™ Rx Nitinol Stent Transhepatic Biliary System is indicated for use in the palliation of malignant neoplasms in the biliary tree.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032137 · printed Nov 3, 2026
Cite this page
510(k) Report. “K032137: Precise RX Nitinol Stent Transhepatic Biliary System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K032137
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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