# K180605: GastroFlush

- Pathway: 510(k) (Traditional)
- Applicant: Bionix Development Corporation
- Decided: Oct 24, 2018 after 231 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: 2 generations back to K905164 (1991). 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)
- K121571: Tubeclear, Actuated Medical, Inc. (2012) Summary page 5.
- K905164: Tube Declogger, Nova Design Technologies, Ltd. (1991) Summary page 5.

## Indications for use
GastroFlush is indicated for use in clearing occlusions/clogs from enteral feeding tubes placed for nutrition and/or decompression in adult or adolescent patients that have tube size 8Fr-24Fr and tube length no longer than 42 inches. It is intended to be used by or under the direction of a licensed physician.

Source page: https://510kreport.com/device/K180605
Methodology: https://510kreport.com/methodology