Steripath® Flow Blood Collection System— 510(k) K251812

Substantially Equivalent

Magnolia Medical Technologies

FDA 510(k) clearance K251812 for Steripath® Flow Blood Collection System, Substantially Equivalent on 2025-09-25. Applicant: Magnolia Medical Technologies. Device class: 2.

Clearance details

Applicant
Magnolia Medical Technologies
Product code
Code JKA
Device class
Class 2
Regulation
21 CFR 862.1675
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Seattle, WA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code JKA

product code JKA
Injury
455
Malfunction
26,686
Other
4
Total
27,145

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.