# K033936: Bard Eliminator Pet Balloon Dilators

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Jan 14, 2004 after 26 days
- Product code: KNQ (Dilator, Esophageal)
- Device class: 2
- Regulation: 21 CFR 876.5365
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bard® ELIMINATOR® PET Balloon Dilators: named in the summary without a submission number

## Recalls of this device
- Apr 16, 2007 · Not classified · Z-0946-2007: Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
- Apr 16, 2007 · Not classified · Z-0937-2007: Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
- Apr 16, 2007 · Not classified · Z-0938-2007: Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
- Apr 16, 2007 · Not classified · Z-0939-2007: Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
- Apr 16, 2007 · Not classified · Z-0940-2007: Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
- Apr 16, 2007 · Not classified · Z-0941-2007: Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
- Apr 16, 2007 · Not classified · Z-0944-2007: 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: Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
- Apr 16, 2007 · Not classified · Z-0948-2007: Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
- Apr 16, 2007 · Not classified · Z-0949-2007: Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
- Apr 16, 2007 · Not classified · Z-0942-2007: Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
- Apr 16, 2007 · Not classified · Z-0943-2007: Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
- Apr 16, 2007 · Not classified · Z-0947-2007: Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.

## Indications for use
To dilate strictures of the GI tract including the colon, pylorus and esophagus.

Source page: https://510kreport.com/device/K033936
Methodology: https://510kreport.com/methodology