# K203633: Enteral Extension Sets

- Pathway: 510(k) (Traditional)
- Applicant: GBUK Group, Ltd.
- Decided: Aug 19, 2021 after 251 days
- Product code: PIF (Gastrointestinal Tubes With Enteral Specific Connectors)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The Enteral Extension Sets with ENFit small bore connectors are intended for enteral feeding, on the order of a physician, to provide a means of delivering enteral nutrition or medication from an enteral feeding syringe through to any feeding tube which will accept a connector for enteral applications. The device is intended for pediatric patients (pediatric subgroups; Newborn (Neonate), Infant, Child, Adolescent) who require enteral feeding.

Source page: https://510kreport.com/device/K203633
Methodology: https://510kreport.com/methodology