# K120685: Zyno Medical Administration Set

- Pathway: 510(k) (Abbreviated)
- Applicant: Zyno Medical, LLC
- Decided: Sep 7, 2012 after 185 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K832284 (1983). 4 ancestors in all.
12 later devices descend from it; 6 cite it directly.
2 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981792: Solution Administration Set, Baxter Healthcare Corp (1998) Summary page 1.
- K973107: Amsino I.V. Administration Set, Amsino Intl., Inc. (1997) Summary page 1.
- K060352: Health Line International Corporations,S IV Administrative Sets, Health Line International Corporation (2006) Summary page 1.

## Most influential descendants
- K151151: U & U Intravascular Administration Set (2015), 5 descendants of its own
- K232316: DEKA Infusion System, DEKA Administration Set (2024), 1 descendant of its own
- K230343: ProSeal™ Closed System Administration Set (2023), 1 descendant of its own
- K173361: IV Administration Set (2018), 1 descendant of its own
- K140783: Halo Ambulatory Infusion System (2014), 1 descendant of its own

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

Source page: https://510kreport.com/device/K120685
Methodology: https://510kreport.com/methodology