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.

Clearance details

Applicant: Magnolia Medical Technologies
Product code: Code JKA
Advisory panel: Clinical Chemistry
Date received: 2025-06-12
Decision date: 2025-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JKA

product code JKA

Injury: 455
Malfunction: 26,686
Other: 4
Total: 27,145

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.