# K221473: Flowart

- Pathway: 510(k) (Traditional)
- Applicant: Asset Medikal Tasarim As.
- Decided: Sep 26, 2022 after 129 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. Needleless valve allows the user to add medication into the primary line without the use of a needle. Power Injection Rating and Flowrate (400 psi and 10 mL/sec).

Source page: https://510kreport.com/device/K221473
Methodology: https://510kreport.com/methodology