# K151237: Nutrisafe 2- ENFit Adaptor

- Pathway: 510(k) (Traditional)
- Applicant: Vygon
- Decided: Feb 9, 2016 after 274 days
- Product code: PIO (Enteral Specific Transition 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 K940556 (1994). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140581: Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit Transition Connector for Medication Port, Cedic S.R.L. (2014) Summary page 4.

## Indications for use
The Nutrisafe 2 – ENFit adaptor is indicated for enteral use only. It enables the connection between an administration set equipped with a female ENFit connector at its distal end and a Nutrisafe 2 feeding tube equipped with a male Nutrisafe 2 connector at its proximal end.

Source page: https://510kreport.com/device/K151237
Methodology: https://510kreport.com/methodology