# K121105: Nutrisafe 2 Feeding Tube

- Pathway: 510(k) (Traditional)
- Applicant: Vygon Corp.
- Decided: Dec 18, 2012 after 250 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: 3 generations back to K820176 (1982). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 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 1.
- K100163: Nutrisafe 2 Feeding Tubes Model 362.XXX. 1362.XXX, Vygon Corp. (2011) Summary page 1.

## Indications for use
For nasogastric/oralgastric enterall feeding, incorporating safety connectors which reduce the risk of misconnections between feeding tubes and intravenous connectors.

Source page: https://510kreport.com/device/K121105
Methodology: https://510kreport.com/methodology