510(k) · Cleared
Recalled · Class II · 2026Cre Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · FDT Duodenoscope And Accessories, Flexible/Rigid
Cleared on Apr 20, 2011 as substantially equivalent to K974788 (Boston Scientific Corp, 1998) after a 26-day review. Its family tree reaches back 1 generation to 1998. 17 later devices descend from it. It has been recalled 6 times.
- Decided
- Apr 20, 2011
- Review
- 26 days
- Class
- Class II
- Product code
- FDT
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974788 (1998). 17 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK974788 Cre (TM) Balloon Dilatation CatheterBoston Scientific Corp · 1998
- This deviceK110833 Cre Balloon Dilatation CatheterBoston Scientific Corporation · 2011
- 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 · 2 generations on · 1 of its ownK172520 CRE RX Biliary Balloon Dilatation CatheterBoston Scientific Corporation · 2017
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
- K172520CRE RX Biliary Balloon Dilatation CatheterBoston Scientific Corporation · 2017 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974788 | Cre (TM) Balloon Dilatation Catheter | Boston Scientific Corp | 1998 | — |
| 0 (this device) | K110833 | Cre Balloon Dilatation Catheter | Boston Scientific Corporation | 2011 | — |
| +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 | — |
| +2 | K172520 | CRE RX Biliary Balloon Dilatation Catheter | Boston Scientific Corporation | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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 FDT? 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 FDT device
- #1 K251861 FUJIFILM Endoscope Model ED-S100TP; FUJIFILM…score 13.7 · 10 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 |
|---|---|---|---|
| * | K974788 | Cre (TM) Balloon Dilatation CatheterSummary page 4…ndoscope and/or accessories 2) Dilator, esophageal Regulation Number: 1) 876.1500 2) 876.5365 Product Code: 1) KOG, 2) KNQ Classification: Class II 3. Predicate Device: K974788 Trade Name: CRE™ Balloon Dilatation Catheter Classification Name: CRE™ Balloon Dilatation Catheter Regulation Number: 1) - 876.15… | 1998 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 21, 2026 | Class II | Z-2634-2026 | Package design/selection | Potential sterile breach of the pouches in which devices are packaged. |
| May 21, 2026 | Class II | Z-2635-2026 | Package design/selection | Potential sterile breach of the pouches in which devices are packaged. |
| May 21, 2026 | Class II | Z-2633-2026 | Package design/selection | Potential sterile breach of the pouches in which devices are packaged. |
| May 21, 2026 | Class II | Z-2632-2026 | Package design/selection | Potential sterile breach of the pouches in which devices are packaged. |
| May 21, 2026 | Class II | Z-2637-2026 | Package design/selection | Potential sterile breach of the pouches in which devices are packaged. |
| May 21, 2026 | Class II | Z-2636-2026 | 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?
How does its category compare?
All FDT devicesFDT Duodenoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · FDT
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FDT
72in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FDT
7so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FDT
3,946in 2025
MAUDE reports naming product code FDT, 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 | 0 | — | 0 | 4 |
| 2008 | 1 | — | 0 | 11 |
| 2009 | 1 | — | 0 | 18 |
| 2010 | 0 | — | 0 | 12 |
| 2011 | 1 | — | 0 | 10 |
| 2012 | 0 | — | 0 | 15 |
| 2013 | 0 | — | 0 | 18 |
| 2014 | 0 | — | 0 | 36 |
| 2015 | 0 | — | 1 | 246 |
| 2016 | 1 | — | 1 | 247 |
| 2017 | 2 | — | 0 | 791 |
| 2018 | 3 | 63 | 1 | 481 |
| 2019 | 5 | 88 | 0 | 1,347 |
| 2020 | 4 | 72 | 0 | 822 |
| 2021 | 2 | — | 1 | 1,270 |
| 2022 | 1 | — | 0 | 2,619 |
| 2023 | 0 | — | 3 | 3,050 |
| 2024 | 2 | — | 0 | 3,019 |
| 2025 | 2 | — | 1 | 3,946 |
| 2026 | 2 | — | 7 | — |
What is it indicated for?
Indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. The recommended application is printed on the package label referring to any combination of esophageal, pyloric and colonic dilatation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K110833 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110833: Cre 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/K110833
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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