# K052881: Vygon Latex Free Bionector

- Pathway: 510(k) (Traditional)
- Applicant: Vygon Corp.
- Decided: Mar 2, 2006 after 141 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K941678 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941678: Bionector, Vygon Corp. (1995) Summary page 1.

## Most influential descendants
- K070705: Modification to: Latex-Free Bionector, Model# 896.019, 896.039 (2007), 0 descendants of its own

## Indications for use
Latex Free Bionector is a multi-purpose catheter accessory; a closed needieless system permitting blood sampling, intermittent injection or continuous infusion of fluids or medications. Connection is exclusively with the Luer system. * Latex Free Bionector is a Male/Female Luer device that displaces a positive bolus during disconnection of the Male Luer devices connected to it.

Source page: https://510kreport.com/device/K052881
Methodology: https://510kreport.com/methodology