# K240965: CORTRAK* 2 Enteral Access System (20-0950)

- Pathway: 510(k) (Traditional)
- Applicant: Avanos Medical, Inc.
- Decided: Jun 6, 2024 after 58 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.
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.

## Indications for use
The Avanos* CORTRAK* 2 Enteral Access System (EAS) utilizes tube tracking technology to assist, in conjunction with institution protocols, qualified clinicians in guiding the placement of Avanos Medical CORTRAK* 2 feeding tubes of 8FR or greater into the stomach or small bowel of patients requiring enteral feeding.

Source page: https://510kreport.com/device/K240965
Methodology: https://510kreport.com/methodology