510(k) · Cleared
ClearedMustang Balloon Dilataion Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on May 12, 2011 as substantially equivalent to K993303 (Boston Scientific Corp, 2000) after a 114-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.
- Decided
- May 12, 2011
- Review
- 114 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993303 (2000). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK993303 Semi Compliant (SC) 35 Balloon Dilatation CatheterBoston Scientific Corp · 2000
- This deviceK110122 Mustang Balloon Dilataion CathetersBoston Scientific · 2011
- Descendant · cites it directly · 0 of its ownK141597 Mustang Balloon Dialation CatheterBoston Scientific Corporation · 2014
- Descendant · cites it directly · 0 of its ownK112701 Charger Balloon Dilatation CatheterBoston Scientific · 2011
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 | K993303 | Semi Compliant (SC) 35 Balloon Dilatation Catheter | Boston Scientific Corp | 2000 | — |
| 0 (this device) | K110122 | Mustang Balloon Dilataion Catheters | Boston Scientific | 2011 | — |
| +1 | K141597 | Mustang Balloon Dialation Catheter | Boston Scientific Corporation | 2014 | — |
| +1 | K112701 | Charger Balloon Dilatation Catheter | Boston Scientific | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 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 |
|---|---|---|---|
| * | K993303 | Semi Compliant (SC) 35 Balloon Dilatation CatheterSummary page 1…tation Catheter Product Code FGE Classification Class 11,21 CFR Part 876.5010 Predicate SC 35 Balloon Dilatation Catheter K993303 23 March 2000 Device Device The Boston Scientific Mustang Tm Balloon Dilatation Catheter is an over-the-… | 2000 |
What descends from it? (2)
2 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?
- Its one ancestor has no recall.
- Of its descendants, K141597 (Boston Scientific Corporation, 2014) has gone furthest, with 0 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. 2011, 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?
The Mustang Balloon Dilatation Catheters with balloons up to 120 mm in length are indicated for the treatment of biliary strictures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110122 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110122: Mustang Balloon Dilataion Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110122
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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