# K250481: Extension Feeding Set with ENFit™ Connectors

- Pathway: 510(k) (Traditional)
- Applicant: SKY Medical, a.s.
- Decided: Apr 18, 2025 after 58 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
Longest line of descent: 2 generations back to K132686 (2014). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141631: Aquarius Extension Feeding Set, Degania Silicone, Ltd. (2014) Summary page 5.

## Indications for use
The Extension Feeding Set with ENFit™ connectors is intended for use as an extension set for a Low-Profile Gastrostomy Replacement Tube (G. Button). It is intended to provide delivery of Enteral Nutrition from administration media with ENFit™ connector and or medication into a single patient, for a maximum of two weeks. Feeding via an Extension Feeding Set is advocated when nutrition cannot be provided to the patient by mouth and therefore cannot consume an adequate number of calories because of an underlying condition. Intended patient population: adult, children older than 1 month.

Source page: https://510kreport.com/device/K250481
Methodology: https://510kreport.com/methodology