# K230326: ENFit to ENFit Extension Sets

- Pathway: 510(k) (Traditional)
- Applicant: Vesco Medical
- Decided: Nov 2, 2023 after 269 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: 3 generations back to K801558 (1980). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143018: Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore Connectors, Covidien (2015) Summary page 4.

## Indications for use
The ENFit to ENFit Extension Sets are intended for enteral feeding, on the order of a physician, to provide a means of delivering enteral nutrition, fluids and medications from an enteral feeding syringe or set through to an ENFit feeding tube connector for enteral applications. The device is single use for patients who require enteral feeding.

Source page: https://510kreport.com/device/K230326
Methodology: https://510kreport.com/methodology