# K023585: Flostar Needleless Connector, Model FS3000

- Pathway: 510(k) (Special)
- Applicant: Intravascular Incorporated
- Decided: Nov 21, 2002 after 27 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) Safe-Connect Valve: named in the summary without a submission number

## Indications for use
The FLOSTAR Needleless Connector device is sterile, disposable, needle-less I.V. access valve for use in intravenous administration of fluids to a patient’s vascular system. The FLOSTAR Needleless Connector device may aid in the prevention of needle stick injuries.

Source page: https://510kreport.com/device/K023585
Methodology: https://510kreport.com/methodology