# K043044: Anti-I.V. Enteral Feeding System

- Pathway: 510(k) (Traditional)
- Applicant: Viasys Medsystems
- Decided: May 6, 2005 after 183 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: 2 (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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Oct 16, 2020 · Class II · Z-0540-2021: Detachment of the Male AIV Adaptor from the Y-Connector.
- Jun 25, 2008 · Not classified · Z-2306-2008: The male Luer adapter may be the wrong component therefore the feeding set would not be able to be connected to the tube nor would the cap fit securely.

## Indications for use
The Anti-I.V. Enteral Feeding System is intended for use in those patients who require intermittent or continuous tube feedings via the nasogastric or nasoentric route. The Anti-I.V. Enteral Feeding Tube is intended for use in those patients who require intermittent or continuous tube feedings via the nasogastric or nasoentric route. The Anti-I.V. Enteral Feeding Extension Set is intended to be used to deliver enteral formula from the nutritional source to the Anti-IN. Enteral Feeding Tube. The Anti-I.V. Enteral Feeding System is for pediatric and neonatal use only.

Source page: https://510kreport.com/device/K043044
Methodology: https://510kreport.com/methodology