# K130611: Entuit Thrive Balloon Retention Gastrostomy Feeding Tube

- Pathway: 510(k) (Traditional)
- Applicant: Xeridiem Medical Devices
- Decided: Dec 19, 2013 after 287 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 K901501 (1990). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083684: Endo Vive Standard Replacement Gastrostomy Tube, Model 82XX, Manufacturing & Research, Inc. (2009) Summary page 2.

## Most influential descendants
- K171347: Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection (2017), 0 descendants of its own

## Indications for use
The EntuitTh Thrive Balloon Retention Gastrostomy Feeding Tube is intended to provide gastric access for enteral feeding, medication administration and decompression through an established gastrointestinal stoma tract. The EntuitTM Thrive Balloon Retention Gastrostomy Feeding Tube is indicated for use in percutaneous placement of an enteral feeding tube in adult and pediatric patients that require enteral feeding, medication administration or decompression through an established gastrointestinal stoma tract.

Source page: https://510kreport.com/device/K130611
Methodology: https://510kreport.com/methodology