# K963981: Vygon Bionector with Extension Set

- Pathway: 510(k) (Traditional)
- Applicant: Vygon Corp.
- Decided: Feb 14, 1997 after 134 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have 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.

## 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 12, 2013 · Class II · Z-2251-2013: Microbore tubing disconnecting from male luers on the extension sets.
- Aug 12, 2013 · Class II · Z-2252-2013: Microbore tubing disconnecting from male luers on the extension sets.

Source page: https://510kreport.com/device/K963981
Methodology: https://510kreport.com/methodology