# K960415: Wilson-Cook Balloon Inflation Device

- Pathway: 510(k) (Traditional)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Apr 26, 1996 after 88 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
Longest line of descent: 1 generation back to K860589 (1986). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K860589: Inflator/Deflator Piston Syringe, Microvasive (1986) Summary page 1.
- K936168: Wilson-Cook Balloon Inflation Device, Wilson-Cook Medical, Inc. (1994) Summary page 1.

## Indications for use
This device is a disposable device to be used to inflate, deflate and monitor pressure for gastrointestinal dilation balloons.

Source page: https://510kreport.com/device/K960415
Methodology: https://510kreport.com/methodology