# K003311: Nutrisafe Pur Enteral Feeding Tube

- Pathway: 510(k) (Traditional)
- Applicant: Vygon Corp.
- Decided: Jan 11, 2002 after 445 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
No predicates in its family tree.
43 later devices descend from it; 1 cites it directly.
1 of 44 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K060944: Nutrisafe 2 (2006), 42 descendants of its own
- 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

Source page: https://510kreport.com/device/K003311
Methodology: https://510kreport.com/methodology