# K080679: Modification to Cortrak Enteral Access Device, Model 20-0900

- Pathway: 510(k) (Traditional)
- Applicant: Viasys Medsystems
- Decided: Jun 27, 2008 after 109 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices 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.

## Most influential descendants
- K182915: ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube (2019), 2 descendants of its own
- K191387: ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube (2019), 1 descendant of its own
- K203133: ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube (2021), 0 descendants of its own

## Indications for use
The CORTRAK™ System is an electrical device designed to aid qualified operators in the placement of VIASYS MedSystems feeding tubes of 8 FR or greater into the stomach or small bowel of patients requiring enteral feeding. Prior to commencing the delivery of food, confirmation of correct tube placement by acceptable hospital protocol is required.

Source page: https://510kreport.com/device/K080679
Methodology: https://510kreport.com/methodology