# K230206: Entarik Feeding Tube System; Entarik Feeding Tube

- Pathway: 510(k) (Traditional)
- Applicant: Gravitas Medical, Inc.
- Decided: Mar 24, 2023 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
Longest line of descent: 4 generations back to K831868 (1983). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142327: smARTrack Feeding Tube System, Art Healthcare, Ltd. (2015) Summary page 5.

## Most influential descendants
- K241169: Entarik NI Feeding Tube System (2024), 0 descendants of its own

## Indications for use
The Entarik Feeding Tube is intended for the administration of nutrition, fluids and medications by the nasoenteric route for patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition. The Entarik Feeding Tube System is designed to aid, in conjunction with institutional protocols, qualified operators in the placement of the Entarik Feeding Tube (Entarik FT) into the stomach of patients requiring enteral feeding. The Entarik FT is equipped with sensors designed to provide information about the location of the tube tip relative to the stomach, thus assisting in reducing the incidence of misplacement during first positioning. The Entarik Monitor also monitors the feeding tube position continuously during the course of feeding and automatically and in real-time alerts of tube migration.

Source page: https://510kreport.com/device/K230206
Methodology: https://510kreport.com/methodology