# K220588: Avanos* CORTRAK* 2 Enteral Access System (EAS)

- Pathway: 510(k) (Traditional)
- Applicant: Avanos Medical, Inc.
- Decided: Apr 22, 2022 after 52 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 K113351 (2012). 2 ancestors in all.
No later device cites it as a predicate yet.
2 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191340: CORTRAK* 2 Equilateral Enteral Access System, Avanos Medical, Inc. (2019) Summary page 4.

## 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 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/K220588
Methodology: https://510kreport.com/methodology