# K243361: Nutrifit

- Pathway: 510(k) (Traditional)
- Applicant: Vygon USA
- Decided: Dec 19, 2024 after 51 days
- Product code: FPD (Tube, Feeding)
- 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 K820176 (1982). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060944: Nutrisafe 2, Vygon Corp. (2006) Summary page 5.

## Indications for use
For nasogastric/ oralgastric enteral feeding, incorporating safety connectors which eliminates the risk of IV administration through the feeding tube.

Source page: https://510kreport.com/device/K243361
Methodology: https://510kreport.com/methodology