# K070705: Modification to: Latex-Free Bionector, Model# 896.019, 896.039

- Pathway: 510(k) (Traditional)
- Applicant: Vygon Corp.
- Decided: Nov 30, 2007 after 261 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K941678 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052881: Vygon Latex Free Bionector, Vygon Corp. (2006)

## Recalls of this device
- Jan 15, 2015 · Class II · Z-1472-2015: Potential for leaking caused by insufficient bond between needleless device and female luer.
- Jan 15, 2015 · Class II · Z-1474-2015: Potential for leaking caused by insufficient bond between needleless device and female luer.
- Jan 15, 2015 · Class II · Z-1470-2015: Potential for leaking caused by insufficient bond between needleless device and female luer.
- Jan 15, 2015 · Class II · Z-1475-2015: Potential for leaking caused by insufficient bond between needleless device and female luer.
- Jan 15, 2015 · Class II · Z-1473-2015: Potential for leaking caused by insufficient bond between needleless device and female luer.
- Jan 15, 2015 · Class II · Z-1467-2015: Potential for leaking caused by insufficient bond between needleless device and female luer.
- Jan 15, 2015 · Class II · Z-1477-2015: Potential for leaking caused by insufficient bond between needleless device and female luer.
- Jan 15, 2015 · Class II · Z-1468-2015: Potential for leaking caused by insufficient bond between needleless device and female luer.
- Jan 15, 2015 · Class II · Z-1478-2015: Potential for leaking caused by insufficient bond between needleless device and female luer.
- Jan 15, 2015 · Class II · Z-1471-2015: Potential for leaking caused by insufficient bond between needleless device and female luer.
- Jan 15, 2015 · Class II · Z-1476-2015: Potential for leaking caused by insufficient bond between needleless device and female luer.
- Jan 15, 2015 · Class II · Z-1469-2015: Potential for leaking caused by insufficient bond between needleless device and female luer.
- Aug 28, 2014 · Class II · Z-0113-2015: Vygon has uncovered potential problems with membrane elasticity in the 896.038, Bionector Needleless connector and is issuing a voluntary recall of the 896.038, Bionector Needleless connector.

## Indications for use
LATEX-FREE BIONECTOR is a multi-purpose catheter accessory; a closed needle-less system permitting blood sampling, intermittent injection or continuous infusion of fluids or medications. Connection is exclusively with the Male/Female Luer system which does not displace fluid upon either connection or disconnection.

Source page: https://510kreport.com/device/K070705
Methodology: https://510kreport.com/methodology