510(k) · Decided
DecidedModificiation to: Biliary Wallstent Endoprostheis with Monorail Delivery System, Model 71-XXX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Scimed, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Oct 24, 2001 as substantially equivalent to K993232 (Boston Scientific Scimed, Inc., 1999) after a 62-day review. Its family tree reaches back 4 generations to 1991. 1 later device descends from it.
- Decided
- Oct 24, 2001
- Review
- 62 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K911292 (1991). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK911292 Schneider Wallstent (R)Pfizer Hospital Products Group, Inc. · 1991
- 3 generations backK961262 Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic…Boston Scientific Scimed, Inc. · 1996
- 2 generations backK964119 Wallstent Transhepatic Biliary EndoprosthesisBoston Scientific Scimed, Inc. · 1997 · Recalled
- 1 generation backK993232 Wallstent Biliary Endoprosthesis and Unistep Plus Delivery SystemBoston Scientific Scimed, Inc. · 1999
- This deviceK012822 Modificiation to: Biliary Wallstent Endoprostheis with Monorail…Boston Scientific Scimed, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK032137 Precise RX Nitinol Stent Transhepatic Biliary SystemCordis Corp. · 2003 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K032137Precise RX Nitinol Stent Transhepatic Biliary SystemCordis Corp. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K911292 | Schneider Wallstent (R) | Pfizer Hospital Products Group, Inc. | 1991 | — |
| −3 | K961262 | Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic Biliary… | Boston Scientific Scimed, Inc. | 1996 | — |
| −2 | K964119 | Wallstent Transhepatic Biliary Endoprosthesis | Boston Scientific Scimed, Inc. | 1997 | 6 |
| −1 | K993232 | Wallstent Biliary Endoprosthesis and Unistep Plus Delivery System | Boston Scientific Scimed, Inc. | 1999 | — |
| 0 (this device) | K012822 | Modificiation to: Biliary Wallstent Endoprostheis with Monorail Delivery… | Boston Scientific Scimed, Inc. | 2001 | — |
| +1 | K032137 | Precise RX Nitinol Stent Transhepatic Biliary System | Cordis Corp. | 2003 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 |
|---|---|---|---|
| * | K993232 | Wallstent Biliary Endoprosthesis and Unistep Plus Delivery SystemSummary page 3…norail Delivery System is manufactured in a substantially equivalent manner to the currently marketed Biliary Wallstent Endoprosthesis with Unistep Plus Delivery System (K993232). The major manufacturing differences are related to the differences in the delivery system design which will be utilized to plac… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032137 | Precise RX Nitinol Stent Transhepatic Biliary System | 2003 | 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?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K032137 (Cordis Corp., 2003) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K993232.
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 Biliary Wallstent® Endoprosthesis with Monorail Delivery System is indicated for
use in the treatment of biliary strictures produced by malignant neoplasms.
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/K012822 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012822: Modificiation to: Biliary Wallstent Endoprostheis with Monorail Delivery System, Model 71-XXX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012822
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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