# K241169: Entarik NI Feeding Tube System

- Pathway: 510(k) (Traditional)
- Applicant: Gravitas Medical, Inc.
- Decided: Nov 22, 2024 after 210 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: 5 generations back to K831868 (1983). 13 ancestors in all.
No later device cites it as a predicate yet.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230206: Entarik Feeding Tube System; Entarik Feeding Tube, Gravitas Medical, Inc. (2023) Summary page 5.
- K202539: Nutriglide (TM) Nasal Feeding Tube, Applied Medical Technology, Inc. (2020) Summary page 5.
- K131590: Innersense Esophageal Temperature Probe / Feeding Tube, Philips Medical Systems (2013) Summary page 5.

## Indications for use
Entarik NI Feeding Tubes (FTs) are intended for the administration of nutrition, fluids and medications by the nasoenteric or orogastric route for neonatal patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition. The Entarik NI Feeding Tube System (Entarik NI System) is designed to aid, in conjunction with institutional protocols, qualified operators in the placement of the Entarik NI Feeding Tube(FT) into the stomach of neonatal patients requiring enteral feeding. The Entarik FTs are 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 NI FTs are provided sterile. The Entarik NI System also monitors the feeding tube position continuously during the course of feeding and automatically and in real time alerts of tube migration. The Entarik NI System provides continuous monitoring of gastric and esophageal temperature. The Entarik device can be used solely for the purpose of monitoring gastric and esophageal temperature in situations where invasive monitoring is indicated. The Entarik NI system is intended to record, store, view and analyze impedance in the pharynx, esophagus and stomach.

Source page: https://510kreport.com/device/K241169
Methodology: https://510kreport.com/methodology