Cleared Traditional

Steripath? Flow? Blood Collection System

K251812 · Magnolia Medical Technologies · General Hospital

Sep 2025

Decision

105d

Days

Class 2

Risk

About This 510(k) Submission

K251812 is an FDA 510(k) clearance for the Steripath? Flow? Blood Collection System, a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II — Special Controls, product code JKA), submitted by Magnolia Medical Technologies (Seattle, US). The FDA issued a Cleared decision on September 25, 2025, 105 days after receiving the submission on June 12, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number	K251812 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 12, 2025
Decision Date	September 25, 2025
Days to Decision	105 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement