510(k) · Cleared
Recalled · Class II · 2021Maxforce Biliary Dilatation Catheter and Hurricane RX Biliary 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 Aug 9, 2013 as substantially equivalent to K910931 (Boston Scientific Corp, 1991) and 1 other predicate after a 165-day review. Its family tree reaches back 1 generation to 1991. 2 later devices descend from it. It has been recalled 9 times.
- Decided
- Aug 9, 2013
- Review
- 165 days
- Class
- Class II
- Product code
- FGE
- Recalls
- 9
- Predicates
- 2
Its longest line of descent runs back 1 generation to K910931 (1991). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK910931 Biliary Balloon Dilatation CatheterBoston Scientific Corp · 1991
- This deviceK130484 Maxforce Biliary Dilatation Catheter and Hurricane RX Biliary CatheterBoston Scientific Corp · 2013
- Descendant · cites it directly · 1 of its ownK172520 CRE RX Biliary Balloon Dilatation CatheterBoston Scientific Corporation · 2017
- Descendant · 2 generations on · 0 of its ownK241888 Single-use Balloon Dilatation CatheterLeo Medical Co., Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910931 | Biliary Balloon Dilatation Catheter | Boston Scientific Corp | 1991 | — |
| 0 (this device) | K130484 | Maxforce Biliary Dilatation Catheter and Hurricane RX Biliary Catheter | Boston Scientific Corp | 2013 | — |
| +1 | K172520 | CRE RX Biliary Balloon Dilatation Catheter | Boston Scientific Corporation | 2017 | — |
| +2 | K241888 | Single-use Balloon Dilatation Catheter | Leo Medical Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2024 | 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? (2)
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 |
|---|---|---|---|
| * | K910931 | Biliary Balloon Dilatation CatheterSummary page 2…on has demonstrated that the proposed "catheter tip" resin is substantially equivalent to the "catheter tip" resin of the currently cleared MaxForce Biliary (K910931) and Hurricane RX Biliary Catheter (1(001338) devices. Special 510(k) Premnrket Notification, MaxForce Biliary Dilatation C… | 1991 |
| * | K001338 | Microvasive Rapid Exchange Biliary Balloon Dilatation CatheterSummary page 2…r tip" resin is substantially equivalent to the "catheter tip" resin of the currently cleared MaxForce Biliary (K910931) and Hurricane RX Biliary Catheter (1(001338) devices. Special 510(k) Premnrket Notification, MaxForce Biliary Dilatation Catheter and Hurricane RX Dilatation Catheter… | 2000 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172520 | CRE RX Biliary Balloon Dilatation Catheter | 2017 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 21, 2021 | Class II | Z-0320-2022 | Device Design | Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure |
| Oct 21, 2021 | Class II | Z-0322-2022 | Device Design | Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure |
| Oct 21, 2021 | Class II | Z-0325-2022 | Device Design | Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure |
| Oct 21, 2021 | Class II | Z-0321-2022 | Device Design | Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure |
| Oct 21, 2021 | Class II | Z-0323-2022 | Device Design | Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure |
| Oct 21, 2021 | Class II | Z-0324-2022 | Device Design | Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure |
| Oct 21, 2021 | Class II | Z-0327-2022 | Device Design | Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure |
| Oct 21, 2021 | Class II | Z-0326-2022 | Device Design | Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure |
| Sep 16, 2020 | Class II | Z-0286-2021 | Vendor change control | RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength. |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2013, this device’s year, is highlighted.
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?
MaxForce Biliary Dilatation Catheter: The MaxForce Biliary Balloon Dilatation Catheters are recommended for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi.
Hurricane RX Biliary Balloon Dilatation Catheter: The Hurricane RX Biliary Balloon Dilatation Catheter is recommended for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. The Hurricane RX Biliary Balloon Dilatation Catheter may be used for injection of contrast medium for fluoroscopic visualization of the bile ducts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130484 · printed Nov 3, 2026
Cite this page
510(k) Report. “K130484: Maxforce Biliary Dilatation Catheter and Hurricane RX Biliary Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K130484
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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