510(k) · Cleared
ClearedCre (TM) Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · KNQ Dilator, Esophageal
Cleared on Mar 20, 1998 after an 88-day review. The FDA summary names its predicate without a number. 19 later devices descend from it.
- Decided
- Mar 20, 1998
- Review
- 88 days
- Class
- Class II
- Product code
- KNQ
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 2 citing it directly.
- This deviceK974788 Cre (TM) Balloon Dilatation CatheterBoston Scientific Corp · 1998
- Descendant · cites it directly · 17 of its ownK110833 Cre Balloon Dilatation CatheterBoston Scientific Corporation · 2011 · Recalled
- Descendant · 2 generations on · 15 of its ownK112994 Cre Ditatation BallonBoston Scientific Corporation · 2012 · Recalled
- Descendant · 3 generations on · 4 of its ownK151671 Disposable Multistage Dilation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd. · 2015
- Descendant · 4 generations on · 3 of its ownK162226 Reliant Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd. · 2017
- Descendant · 5 generations on · 2 of its ownK180418 Reliant (TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd. · 2018
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K110833Cre Balloon Dilatation CatheterBoston Scientific Corporation · 2011 · cites it directly17descendants
- K112994Cre Ditatation BallonBoston Scientific Corporation · 2012 · 2 generations on15descendants
- K151671Disposable Multistage Dilation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd. · 2015 · 3 generations on4descendants
- K162226Reliant Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd. · 2017 · 4 generations on3descendants
- K180418Reliant (TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd. · 2018 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974788 | Cre (TM) Balloon Dilatation Catheter | Boston Scientific Corp | 1998 | — |
| +1 | K110833 | Cre Balloon Dilatation Catheter | Boston Scientific Corporation | 2011 | 6 |
| +2 | K112994 | Cre Ditatation Ballon | Boston Scientific Corporation | 2012 | 6 |
| +3 | K151671 | Disposable Multistage Dilation Balloon Catheter | Micro-Tech (Nanjing) Co., Ltd. | 2015 | — |
| +4 | K162226 | Reliant Multistage Dilatation Balloon Catheter | Micro-Tech (Nanjing) Co., Ltd. | 2017 | — |
| +5 | K180418 | Reliant (TM) Multistage Dilatation Balloon Catheter | Micro-Tech (Nanjing) Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2011 | 1 | 0 |
| 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 KNQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | CRE™ Balloon Dilatation Catheter Named without a submission number | |
| * | — | Vector TTS™ Balloon Dilatation Catheter Named without a submission number |
What descends from it? (19)
See all 192 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?
- Of its descendants, K110833 (Boston Scientific Corporation, 2011) has gone furthest, with 17 descendants of its own.
How does its category compare?
All KNQ devicesKNQ Dilator, Esophageal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNQ
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · KNQ
121in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNQ
14in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KNQ
282in 2025
MAUDE reports naming product code KNQ, 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 | — | 14 | 22 |
| 2008 | 0 | — | 0 | 128 |
| 2009 | 3 | 121 | 0 | 391 |
| 2010 | 0 | — | 0 | 176 |
| 2011 | 0 | — | 0 | 251 |
| 2012 | 1 | — | 0 | 251 |
| 2013 | 0 | — | 0 | 228 |
| 2014 | 0 | — | 0 | 164 |
| 2015 | 0 | — | 0 | 204 |
| 2016 | 0 | — | 0 | 154 |
| 2017 | 0 | — | 0 | 231 |
| 2018 | 0 | — | 0 | 396 |
| 2019 | 0 | — | 0 | 388 |
| 2020 | 0 | — | 0 | 364 |
| 2021 | 0 | — | 0 | 351 |
| 2022 | 0 | — | 0 | 274 |
| 2023 | 0 | — | 0 | 319 |
| 2024 | 0 | — | 0 | 268 |
| 2025 | 0 | — | 0 | 282 |
| 2026 | 0 | — | 4 | — |
What is it indicated for?
The Modified Balloon Dilatation Catheters are 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.*
* The recommended application on the label may refer 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/K974788 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974788: Cre (TM) Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974788
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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