# K974571: Solution Administration Set with Capped Luer Activated Valve

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: May 21, 1998 after 164 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. The FDA summary names its predicate without a number.
- (no number) Abbott I.V. Sets with Capped Reflux Valve Port: named in the summary without a submission number

## Indications for use
Baxter solution administration sets with capped luer activated valves are intended for use with a vascular access device for the administration of drugs and solutions. The capped luer activated valve will replace the Y-injection site on the set. The valve can be connected to standard male luer adapters (e.g., syringes or sets), for continuous or intermittent fluid administration or the withdrawal of fluids.

Source page: https://510kreport.com/device/K974571
Methodology: https://510kreport.com/methodology