# K132841: Zyno Medical Administration Set

- Pathway: 510(k) (Special)
- Applicant: Zyno Medical, LLC
- Decided: Jan 23, 2014 after 135 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K832284 (1983). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120685: Zyno Medical Administration Set, Zyno Medical, LLC (2012) Summary page 3.

## Recalls of this device
- May 29, 2019 · Class II · Z-2058-2019: Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administration set to be pumped to the proximal end of the tubing when secondary set is used with the
- May 29, 2019 · Class II · Z-2059-2019: Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administration set to be pumped to the proximal end of the tubing when secondary set is used with the
- Jul 29, 2016 · Class II · Z-2896-2016: Administration Set potential filter leaking
- Jul 29, 2016 · Class II · Z-2893-2016: Administration Set potential filter leaking
- Jul 29, 2016 · Class II · Z-2895-2016: Administration Set potential filter leaking
- Jul 29, 2016 · Class II · Z-2894-2016: Administration Set potential filter leaking

## Indications for use
Zyno Medical Administration Set is a device used to administer fluids from a container to a patient's vascular system through a needle or a catheter inserted into a vein.

Source page: https://510kreport.com/device/K132841
Methodology: https://510kreport.com/methodology