# K142327: smARTrack Feeding Tube System

- Pathway: 510(k) (Traditional)
- Applicant: Art Healthcare, Ltd.
- Decided: Jun 8, 2015 after 292 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: 3 generations back to K831868 (1983). 6 ancestors in all.
2 later devices descend 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)
- K113351: Cortrak Enteral Access Device, Corpak Medsystems (2012) Summary page 5.
- K123555: Kangaroo Feeding Tubes with Iris Technology, Covidien (2014) Summary page 5.
- K012232: Insight, Model S980000, Sandhill Scientific, Inc. (2002) Summary page 5.

## Most influential descendants
- K230206: Entarik Feeding Tube System; Entarik Feeding Tube (2023), 1 descendant of its own
- K241169: Entarik NI Feeding Tube System (2024), 0 descendants of its own

## Indications for use
The smARTrack™ Feeding Tube System is designed to aid qualified operators in the placement of the smARTrack Feeding Tube into the stomach of patients requiring enteral feeding. The smARTrack™ tube is equipped with sensors designed to provide information about the location of the tube tip relative to the lower esophageal sphincter (LES) thus assisting in reducing the incidence of misplacement during first positioning. The smARTrack™ tube also monitors the position continuously during the course of the feeding and automatically and in real time alerts of tube migration. The smARTrack console is equipped with a motorized mechanism which automatically and in real-time stops feeding if the feeding tube moves out of position during ongoing use. Furthermore, smARTrack™ Feeding Tube System can guide operator to correctly re-position the tube. The smARTrack™ Feeding Tube is intended for gastric decompression, gastric lavage, and the administration of nutrition, fluids and medications by the naso-enteric route for patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition.

Source page: https://510kreport.com/device/K142327
Methodology: https://510kreport.com/methodology