# K222889: FlowArt® Needle-Free Split Septum Valve

- Pathway: 510(k) (Traditional)
- Applicant: Asset Medikal Tasarim San Tic As.
- Decided: Jan 20, 2023 after 119 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
FlowArt® Needle-Free Split Septum Valve: Needle-free valve is intended for use as an accessory to a vascular access device used in Hemodialysis or as an accessory to an Intravascular Administration Set for the administration or withdraw of fluids to a patient through a cannula or needle placed in the vein.

Source page: https://510kreport.com/device/K222889
Methodology: https://510kreport.com/methodology