510(k) · Cleared
ClearedCRE RX Biliary Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Oct 4, 2017 as substantially equivalent to K112994 (Boston Scientific Corporation, 2012) and 1 other predicate after a 44-day review. Its family tree reaches back 3 generations to 1998. 1 later device descends from it.
- Decided
- Oct 4, 2017
- Review
- 44 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K974788 (1998). 6 ancestors in all, the oldest K910931 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK974788 Cre (TM) Balloon Dilatation CatheterBoston Scientific Corp · 1998
- 2 generations backK110833 Cre Balloon Dilatation CatheterBoston Scientific Corporation · 2011 · Recalled
- 1 generation backK112994 Cre Ditatation BallonBoston Scientific Corporation · 2012 · Recalled
- This deviceK172520 CRE RX Biliary Balloon Dilatation CatheterBoston Scientific Corporation · 2017
- Descendant · cites it directly · 0 of its ownK241888 Single-use Balloon Dilatation CatheterLeo Medical Co., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K241888Single-use Balloon Dilatation CatheterLeo Medical Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K974788 | Cre (TM) Balloon Dilatation Catheter | Boston Scientific Corp | 1998 | — |
| −2 | K110833 | Cre Balloon Dilatation Catheter | Boston Scientific Corporation | 2011 | 6 |
| −1 | K112994 | Cre Ditatation Ballon | Boston Scientific Corporation | 2012 | 6 |
| 0 (this device) | K172520 | CRE RX Biliary Balloon Dilatation Catheter | Boston Scientific Corporation | 2017 | — |
| +1 | K241888 | Single-use Balloon Dilatation Catheter | Leo Medical Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2000 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K112994 | Cre Ditatation BallonSummary page 4…Code: FGE Classification: Class II 3. Predicate Device: Trade Name: CRE™ PRO Wireguided Balloon Dilatation Balloon 510(k) Number: K112994 Classification Name: Biliary Catheter and Accessories Regulation Number: 876.5010 Product Code: FGE Classificat… | 2012 |
| * | K130484 | Maxforce Biliary Dilatation Catheter and Hurricane RX Biliary CatheterSummary page 4…876.5010 Product Code: FGE Classification: Class II Trade Name: Hurricane™ RX Biliary Balloon Dilatation Catheter 510(k) Number: K130484 Classification Name: Biliary Catheter and Accessories Regulation Number: 876.5010 Product Code: FGE Classificat… | 2013 |
| † | K170759 | CRE Pulmonary Balloon Dilatation Catheter | 2017 |
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 |
|---|---|---|---|
| K241888 | Single-use Balloon Dilatation Catheter | 2024 | 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 19 years and passes through 2 companies; a new generation was cleared every 5.6 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K241888 (Leo Medical Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K112994.
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. 2017, 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?
CRE™ RX Biliary Balloon Dilatation Catheter is indicated for use in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy. The CRE™ RX Biliary Balloon Dilatation Catheters 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/K172520 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172520: CRE RX 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/K172520
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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