# K080660: IV Administration Set

- Pathway: 510(k) (Traditional)
- Applicant: U.S. Safety Syringes Co., Inc.
- Decided: May 13, 2008 after 64 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
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’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The US Safety Syringes IV Administration set is used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. The device may include the tubing, a flow regulator, filter, drip chamber, Y port, needless injection port, backflow valve, fluid delivery tubing, connectors between parts of the set and a hollow spike to connect the tubing to an IV bag or medication bag.

Source page: https://510kreport.com/device/K080660
Methodology: https://510kreport.com/methodology