# K191340: CORTRAK* 2 Equilateral Enteral Access System

- Pathway: 510(k) (Special)
- Applicant: Avanos Medical, Inc.
- Decided: Jun 4, 2019 after 15 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K113351 (2012). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
2 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113351: Cortrak Enteral Access Device, Corpak Medsystems (2012) Summary page 4.

## Most influential descendants
- K220588: Avanos* CORTRAK* 2 Enteral Access System (EAS) (2022), 0 descendants of its own

## Recalls of this device
- Mar 21, 2022 · Class I · Z-1032-2022: Product labeling is being modified. STOP using the Anonymous Account Mode feature of the CORTRAK 2 device immediately. CONFIRM placement of the NG/NI tube per institution protocol.

## Indications for use
CORTRAK* 2 Equilateral Enteral Access System is an electrical device designed to aid qualified operators in the placement of Avanos NG feeding tubes of 8 FR or greater into the stomach or small bowel of patients requiring enteral feeding. CORTRAK* 2 Equilateral Enteral Access System can be used to confirm placement of feeding tubes prior to commencing the delivery of enteral nutrition.

Source page: https://510kreport.com/device/K191340
Methodology: https://510kreport.com/methodology