510(k) · Cleared
Recalled · 2007Bard Eliminator Pet Balloon Dilators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · KNQ Dilator, Esophageal
Cleared on Jan 14, 2004 after a 26-day review. The FDA summary names its predicate without a number. It has been recalled 13 times.
- Decided
- Jan 14, 2004
- Review
- 26 days
- Class
- Class II
- Product code
- KNQ
- Recalls
- 13
- Predicates
- 0
The FDA summary names its predicate without a number.
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? (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 |
|---|---|---|---|
| * | — | Bard® ELIMINATOR® PET Balloon Dilators Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 16, 2007 | Not classified | Z-0946-2007 | Other | Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator. |
| Apr 16, 2007 | Not classified | Z-0937-2007 | Other | Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator. |
| Apr 16, 2007 | Not classified | Z-0938-2007 | Other | Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator. |
| Apr 16, 2007 | Not classified | Z-0939-2007 | Other | Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator. |
| Apr 16, 2007 | Not classified | Z-0940-2007 | Other | Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator. |
| Apr 16, 2007 | Not classified | Z-0941-2007 | Other | Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator. |
| Apr 16, 2007 | Not classified | Z-0944-2007 | Other | Complaints received regarding PET Balloon Dilators for a variety of labeling errors, including: incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator. |
| Apr 16, 2007 | Not classified | Z-0945-2007 | Other | Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator. |
| Apr 16, 2007 | Not classified | Z-0948-2007 | Other | Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator. |
| Apr 16, 2007 | Not classified | Z-0949-2007 | Other | Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator. |
| Apr 16, 2007 | Not classified | Z-0942-2007 | Other | Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator. |
| Apr 16, 2007 | Not classified | Z-0943-2007 | Other | Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator. |
| Apr 16, 2007 | Not classified | Z-0947-2007 | Other | Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator. |
The 5 latest of 13 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
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?
To dilate strictures of the GI tract including the colon, pylorus and esophagus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033936 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033936: Bard Eliminator Pet Balloon Dilators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033936
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026