510(k) · Cleared
ClearedBiliary 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 Apr 2, 1991 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 17 later devices descend from it.
- Decided
- Apr 2, 1991
- Review
- 27 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 0
17 later devices descend from it, 2 citing it directly.
- This deviceK910931 Biliary Balloon Dilatation CatheterBoston Scientific Corp · 1991
- Descendant · cites it directly · 15 of its ownK112994 Cre Ditatation BallonBoston Scientific Corporation · 2012 · Recalled
- Descendant · 2 generations on · 4 of its ownK151671 Disposable Multistage Dilation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd. · 2015
- Descendant · 3 generations on · 3 of its ownK162226 Reliant Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd. · 2017
- Descendant · 4 generations on · 2 of its ownK180418 Reliant (TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd. · 2018
- Descendant · cites it directly · 2 of its ownK130484 Maxforce Biliary Dilatation Catheter and Hurricane RX Biliary CatheterBoston Scientific Corp · 2013 · Recalled
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K112994Cre Ditatation BallonBoston Scientific Corporation · 2012 · cites it directly15descendants
- K151671Disposable Multistage Dilation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd. · 2015 · 2 generations on4descendants
- K162226Reliant Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd. · 2017 · 3 generations on3descendants
- K180418Reliant (TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd. · 2018 · 4 generations on2descendants
- K130484Maxforce Biliary Dilatation Catheter and Hurricane RX Biliary CatheterBoston Scientific Corp · 2013 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K910931 | Biliary Balloon Dilatation Catheter | Boston Scientific Corp | 1991 | — |
| +1 | K112994 | Cre Ditatation Ballon | Boston Scientific Corporation | 2012 | 6 |
| +2 | K151671 | Disposable Multistage Dilation Balloon Catheter | Micro-Tech (Nanjing) Co., Ltd. | 2015 | — |
| +3 | K162226 | Reliant Multistage Dilatation Balloon Catheter | Micro-Tech (Nanjing) Co., Ltd. | 2017 | — |
| +4 | K180418 | Reliant (TM) Multistage Dilatation Balloon Catheter | Micro-Tech (Nanjing) Co., Ltd. | 2018 | — |
| +1 | K130484 | Maxforce Biliary Dilatation Catheter and Hurricane RX Biliary Catheter | Boston Scientific Corp | 2013 | 9 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (17)
See all 172 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K112994 (Boston Scientific Corporation, 2012) has gone furthest, with 15 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 | — |
https://510kreport.com/device/K910931 · printed Nov 6, 2026
Cite this page
510(k) Report. “K910931: Biliary 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/K910931
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026