# K191387: ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube

- Pathway: 510(k) (Special)
- Applicant: Envizion Medical, Ltd.
- Decided: Jun 14, 2019 after 21 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 K821906 (1982). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182915: ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube, Envizion Medical, Ltd. (2019) Summary page 4.

## Most influential descendants
- K203133: ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube (2021), 0 descendants of its own

## Indications for use
The ENvizion Medical ENvue System is designed to aid qualified operators in the placement of the ENvizion Medical Enteral Feeding Tube of 10 Fr and 12 Fr into the stomach or small intestine of adult patients requiring enteral feeding. The ENvizion Medical ENvue System is intended as an adjunct to current placement practices for assisting clinical practitioners who place feeding tubes. The ENvizion Medical Enteral Feeding Tube (EFT) has been specifically designed for use with the ENvue System and is intended for placement in the stomach or small intestine. It is intended for use in adult patients who require intermittent or continuous feeding via the oro/nasoenteric route. The EFT is intended only to be used with a feeding pump and is not compatible with gravity-based feeding bags.

Source page: https://510kreport.com/device/K191387
Methodology: https://510kreport.com/methodology