510(k) · Cleared
Recalled · Class II · 2026Cre Ditatation Ballon
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 Feb 10, 2012 as substantially equivalent to K110833 (Boston Scientific Corporation, 2011) and 2 other predicates after a 126-day review. Its family tree reaches back 2 generations to 1998. 15 later devices descend from it. It has been recalled 6 times.
- Decided
- Feb 10, 2012
- Review
- 126 days
- Class
- Class II
- Product code
- FGE
- Recalls
- 6
- Predicates
- 3
Its longest line of descent runs back 2 generations to K974788 (1998). 4 ancestors in all, the oldest K910931 (1991). 15 later devices descend from it, 10 citing it directly.
- Root · 2 generations backK974788 Cre (TM) Balloon Dilatation CatheterBoston Scientific Corp · 1998
- 1 generation backK110833 Cre Balloon Dilatation CatheterBoston Scientific Corporation · 2011 · Recalled
- This deviceK112994 Cre Ditatation BallonBoston Scientific Corporation · 2012
- Descendant · cites it directly · 4 of its ownK151671 Disposable Multistage Dilation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd. · 2015
- Descendant · 2 generations on · 3 of its ownK162226 Reliant Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd. · 2017
- Descendant · 3 generations on · 2 of its ownK180418 Reliant (TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK172520 CRE RX Biliary Balloon Dilatation CatheterBoston Scientific Corporation · 2017
- Descendant · cites it directly · 1 of its ownK150142 Single Use Balloon Dilator V (with Knife)Olympus Medical Systems Corp. · 2015
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K151671Disposable Multistage Dilation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd. · 2015 · cites it directly4descendants
- K162226Reliant Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd. · 2017 · 2 generations on3descendants
- K180418Reliant (TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd. · 2018 · 3 generations on2descendants
- K172520CRE RX Biliary Balloon Dilatation CatheterBoston Scientific Corporation · 2017 · cites it directly1descendant
- K150142Single Use Balloon Dilator V (with Knife)Olympus Medical Systems Corp. · 2015 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K974788 | Cre (TM) Balloon Dilatation Catheter | Boston Scientific Corp | 1998 | — |
| −1 | K110833 | Cre Balloon Dilatation Catheter | Boston Scientific Corporation | 2011 | 6 |
| 0 (this device) | K112994 | Cre Ditatation Ballon | Boston Scientific Corporation | 2012 | — |
| +1 | K151671 | Disposable Multistage Dilation Balloon Catheter | Micro-Tech (Nanjing) Co., Ltd. | 2015 | — |
| +2 | K162226 | Reliant Multistage Dilatation Balloon Catheter | Micro-Tech (Nanjing) Co., Ltd. | 2017 | — |
| +3 | K180418 | Reliant (TM) Multistage Dilatation Balloon Catheter | Micro-Tech (Nanjing) Co., Ltd. | 2018 | — |
| +1 | K172520 | CRE RX Biliary Balloon Dilatation Catheter | Boston Scientific Corporation | 2017 | — |
| +1 | K150142 | Single Use Balloon Dilator V (with Knife) | Olympus Medical Systems Corp. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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? (3)
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 |
|---|---|---|---|
| * | K110833 | Cre Balloon Dilatation Catheter | 2011 |
| * | K001338 | Microvasive Rapid Exchange Biliary Balloon Dilatation CatheterSummary page 1…2) KNQ Classification: Class 1I Trade Name: Hurricane RX Biliary Balloon Dilatation Catheter Manufacturer and Clearance Number: Boston Scientific Corporation K001338 Classification Name: Catheter, Biliary, Diagnostic Regulation Number: 876.5010 Product Code: FUE Classification: HI… | 2000 |
| * | K910931 | Biliary Balloon Dilatation CatheterSummary page 1…ation Number: 876.5010 Product Code: FUE Classification: HI Trade Name: Maxforce Biliary Manufacturer and Clearance Number: Boston Scientific Corporation, K9 10931 Classification Name: Catheter, Biliary, Diagnostic Regulation Number: 876.50 10 Product Code: FGE Classification:… | 1991 |
What descends from it? (15)
See all 1510 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151671 | Disposable Multistage Dilation Balloon Catheter | 2015 | 4 |
| K172520 | CRE RX Biliary Balloon Dilatation Catheter | 2017 | 1 |
| K150142 | Single Use Balloon Dilator V (with Knife) | 2015 | 1 |
| K143609 | Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter | 2015 | 1 |
| K253987 | BARE Wireguided Balloon Dilation Catheter (1235) | 2026 | 0 |
| K241888 | Single-use Balloon Dilatation Catheter | 2024 | 0 |
| K232245 | VedDilator ^TM (3-Stage Balloon Dilation Catheter) | 2024 | 0 |
| K222663 | MultiStage Balloon Dilatation Catheter | 2023 | 0 |
| K180086 | Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter | 2018 | 0 |
| K151925 | Elation Wireguided Balloon Dilation Catheter | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 21, 2026 | Class II | Z-2628-2026 | Package design/selection | Potential sterile breach of the pouches in which devices are packaged. |
| May 21, 2026 | Class II | Z-2631-2026 | Package design/selection | Potential sterile breach of the pouches in which devices are packaged. |
| May 21, 2026 | Class II | Z-2630-2026 | Package design/selection | Potential sterile breach of the pouches in which devices are packaged. |
| May 21, 2026 | Class II | Z-2627-2026 | Package design/selection | Potential sterile breach of the pouches in which devices are packaged. |
| May 21, 2026 | Class II | Z-2626-2026 | Package design/selection | Potential sterile breach of the pouches in which devices are packaged. |
| May 21, 2026 | Class II | Z-2629-2026 | Package design/selection | Potential sterile breach of the pouches in which devices are packaged. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 13.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K151671 (Micro-Tech (Nanjing) Co., Ltd., 2015) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K110833.
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. 2012, 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 CRETM Wireguided Balloon Dilatation Catheter is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in. adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112994 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112994: Cre Ditatation Ballon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112994
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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