# K151151: U & U Intravascular Administration Set

- Pathway: 510(k) (Traditional)
- Applicant: U&U Medical Technology Co, Ltd.
- Decided: Sep 24, 2015 after 147 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: 3 generations back to K832284 (1983). 5 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 11 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 4.

## Most influential descendants
- K230343: ProSeal™ Closed System Administration Set (2023), 1 descendant of its own
- K173361: IV Administration Set (2018), 1 descendant of its own
- K251814: EZ™ IV Administration Set (2025), 0 descendants of its own
- K213778: IV Administration Set (2022), 0 descendants of its own
- K191640: TK Intravascular Administration Set (2020), 0 descendants of its own

## Indications for use
The U&U Intravascular 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/K151151
Methodology: https://510kreport.com/methodology