# K991918: Nutrisafe Extension Tube

- Pathway: 510(k) (Traditional)
- Applicant: Vygon Corp.
- Decided: Oct 29, 1999 after 144 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
48 later devices descend from it; 2 cite it directly.
1 of 49 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K060944: Nutrisafe 2 (2006), 42 descendants of its own
- K082654: Enteral Only Extension Set (2008), 40 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

## Recalls of this device
- 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
The Nutrisafe Extension Tube is intended for use with the Nutrisafe Feeding Tube, which incorporates safety luer lock hub connectors, which eliminate the risk of I.V. administration through the feeding tube. The Nutrisafe Extension Tube will allow 150 cm of additional tubing for the clinician to utilize, where necessary.

Source page: https://510kreport.com/device/K991918
Methodology: https://510kreport.com/methodology