Magnolia Medical Technologies · Class II · Cleared Sep 25, 2025
| K-number | K251812 |
| Device name | Steripath® Flow Blood Collection System |
| Applicant | Magnolia Medical Technologies |
| Product code | JKA |
| Device class | Class II |
| Decision date | Sep 25, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 862.1675 |
The Steripath® Flow™ Blood Collection System is a blood collection system designed to draw blood for in vitro diagnostic testing. It diverts and sequesters the initial specimen prior to collection of a subsequent test sample to reduce blood culture contamination. Components of the system may also be used for infusion following sample collection after disconnection of the Initial Specimen Diversion Device (ISDD).
Not stated in this summary.
Not stated.
The device is indicated for blood collection with an initial specimen diversion feature to reduce contamination in blood cultures. The substantial equivalence determination is based on comparison to predicate blood specimen collection devices that are legally marketed, with the diversion mechanism representing a design variation that does not raise new questions of safety or effectiveness relative to standard blood collection procedures.
View the full FDA submission: accessdata.fda.gov