# K113351: Cortrak Enteral Access Device

- Pathway: 510(k) (Special)
- Applicant: Corpak Medsystems
- Decided: Jan 10, 2012 after 57 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
2 of 6 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
- K142327: smARTrack Feeding Tube System (2015), 2 descendants of its own
- K230206: Entarik Feeding Tube System; Entarik Feeding Tube (2023), 1 descendant of its own
- K191340: CORTRAK* 2 Equilateral Enteral Access System (2019), 1 descendant of its own
- K241169: Entarik NI Feeding Tube System (2024), 0 descendants of its own
- 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
The CORTHAK 2 System is an electrical device designed to aid qualified operators in the placement of the CORPAK MedSystems feeding tubes of 8 FR or greater into the stomach or small bowel of patients requiring enteral feeding. CORTRAK 2 can be used to confirm placement of feeding tubes prior to commencing the delivery of enteral nutrition.

Source page: https://510kreport.com/device/K113351
Methodology: https://510kreport.com/methodology