# K190806: Flowart

- Pathway: 510(k) (Traditional)
- Applicant: Asset Medikal Tasarim As.
- Decided: Feb 20, 2020 after 328 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
Extension sets are for administering fluids from container to a patient's vascular system through a vascular access device. Used for the removal of particulate matter and elimination of air from infusion fluids while administering. Stopcocks are intended for use to change the direction of flow of fluids through a tubing set. Needleless valve allows the user to add medication into the primary line without the use of a needle.

Source page: https://510kreport.com/device/K190806
Methodology: https://510kreport.com/methodology