# K060944: Nutrisafe 2

- Pathway: 510(k) (Special)
- Applicant: Vygon Corp.
- Decided: Sep 15, 2006 after 162 days
- Product code: FPD (Tube, Feeding)
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K820176 (1982). 3 ancestors in all.
42 later devices descend from it; 7 cite it directly.
1 of 46 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991918: Nutrisafe Extension Tube, Vygon Corp. (1999) Summary page 1.
- K003311: Nutrisafe Pur Enteral Feeding Tube, Vygon Corp. (2002) Summary page 1.
- K820176: Vygon Enternal Nutrition Tubes, Exco, Inc. (1982) Summary page 1.

## Most influential descendants
- K100099: Oral/Enteral Syringes (2010), 35 descendants of its own
- K112434: BD Oral/Enteral Syringe with BD Univia Connection (2011), 33 descendants of its own
- K142128: Kangaroo Enteral Feeding Syringes with Enfit Connector (2015), 31 descendants of its own
- K152857: NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps (2015), 30 descendants of its own
- K161039: NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL) (2016), 21 descendants of its own

## Recalls of this device
- Jul 24, 2017 · Class II · Z-0678-2018: Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyve
- Jan 29, 2010 · Not classified · Z-1204-2010: Mislabeled feeding syringes : 12 ml syringe mislabeled as 10 ml.
- Jan 29, 2010 · Not classified · Z-1203-2010: Mislabeled feeding syringes : 6 ml syringe mislabeled as 5 ml.

## 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/K060944
Methodology: https://510kreport.com/methodology