510(k) · Cleared
ClearedUltra-Thin SDS Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Nov 28, 2001 as substantially equivalent to K973008 (Boston Scientific Corp, 1997) after a 162-day review. Its family tree reaches back 1 generation to 1997. 5 later devices descend from it.
- Decided
- Nov 28, 2001
- Review
- 162 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K973008 (1997). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK973008 Courier ST Balloon Dilatation CatheterBoston Scientific Corp · 1997
- This deviceK011909 Ultra-Thin SDS Balloon Dilatation CatheterBoston Scientific Corp · 2001
- Descendant · cites it directly · 4 of its ownK021630 Boston Scientific Express Biliary LD Premounted Stent SystemBoston Scientific Corp · 2002
- Descendant · 2 generations on · 3 of its ownK024048 Modification to Boston Scientific Express Biliary LD Premounted…Boston Scientific Scimed, Inc. · 2003
- Descendant · 2 generations on · 2 of its ownK030645 Boston Scientific Express Biliary LD Unmounted StentBoston Scientific Corp · 2003
- Descendant · 2 generations on · 1 of its ownK032360 Modification to Boston Scientific Express Biliary LD Premounted…Boston Scientific Corp · 2003
- Descendant · 2 generations on · 0 of its ownK133110 Express LD Biliary Premounted Stent SystemBoston Scientific Corporation · 2014
Most influential descendants
Showing 5 of 5 · See all- K021630Boston Scientific Express Biliary LD Premounted Stent SystemBoston Scientific Corp · 2002 · cites it directly4descendants
- K024048Modification to Boston Scientific Express Biliary LD Premounted Stent SystemBoston Scientific Scimed, Inc. · 2003 · 2 generations on3descendants
- K030645Boston Scientific Express Biliary LD Unmounted StentBoston Scientific Corp · 2003 · 2 generations on2descendants
- K032360Modification to Boston Scientific Express Biliary LD Premounted Stent System and Express…Boston Scientific Corp · 2003 · 2 generations on1descendant
- K133110Express LD Biliary Premounted Stent SystemBoston Scientific Corporation · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973008 | Courier ST Balloon Dilatation Catheter | Boston Scientific Corp | 1997 | — |
| 0 (this device) | K011909 | Ultra-Thin SDS Balloon Dilatation Catheter | Boston Scientific Corp | 2001 | — |
| +1 | K021630 | Boston Scientific Express Biliary LD Premounted Stent System | Boston Scientific Corp | 2002 | — |
| +2 | K024048 | Modification to Boston Scientific Express Biliary LD Premounted Stent System | Boston Scientific Scimed, Inc. | 2003 | — |
| +2 | K030645 | Boston Scientific Express Biliary LD Unmounted Stent | Boston Scientific Corp | 2003 | — |
| +2 | K032360 | Modification to Boston Scientific Express Biliary LD Premounted Stent System… | Boston Scientific Corp | 2003 | — |
| +2 | K133110 | Express LD Biliary Premounted Stent System | Boston Scientific Corporation | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K973008 | Courier ST Balloon Dilatation CatheterSummary page 1…remarket notification as the predicate device for the Ultra-Thin SDS Balloon Dilatation Catheter: Boston Scientific Corporation -- Marshal Balloon Dilatation Catheter (K973008) The device mentioned above has been determined substantially equivalent by FDA. 000054 P 2[2 Ultra-Thin SDS B… | 1997 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021630 | Boston Scientific Express Biliary LD Premounted Stent System | 2002 | 4 |
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?
- Its one ancestor has no recall.
- Of its descendants, K021630 (Boston Scientific Corp, 2002) has gone furthest, with 4 descendants of its own.
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?
Ultra-Thin SDS Balloon Dilatation Catheters are indicated for stent
deployent/optimization of the Johnson & Johnson Palmaz® Biliary Stent and for the
treatment of biliary strictures.
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/K011909 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011909: Ultra-Thin SDS Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011909
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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