# K251812: Steripath® Flow™ Blood Collection System

- Pathway: 510(k) (Traditional)
- Applicant: Magnolia Medical Technologies
- Decided: Sep 25, 2025 after 105 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- 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
The Steripath® Flow ™ Blood Collection System is a system to draw blood for in vitro diagnostic testing. The Steripath® Flow ™ Blood Collection System is indicated for use as a blood collection system that diverts and sequesters the initial specimen prior to collection of a subsequent test sample to reduce the frequency of blood culture contamination when contaminants are present in the initial blood sample compared to blood cultures drawn with standard procedure without manual diversion. Additionally, components of the system may be used for infusion following sample collection after disconnection of the Initial Specimen Diversion Device® (ISDD®).

Source page: https://510kreport.com/device/K251812
Methodology: https://510kreport.com/methodology