# K991375: Bard Balloon Inflation System

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Sep 10, 1999 after 142 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: none
- 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) USCI Presto Disposable Inflation Device: named in the summary without a submission number
- (no number) Quantum Inflation Device: named in the summary without a submission number
- (no number) Wilson-Cook Balloon Inflation Device: named in the summary without a submission number

## Indications for use
The inflation system is recommended for use during esophageal, pyloric and colonic balloon dilatation to inflate and deflate balloon dilators and to monitor the pressure within the balloon.

Source page: https://510kreport.com/device/K991375
Methodology: https://510kreport.com/methodology