Cleared Traditional

Steripath Micro Blood Collection System

K222299 · Magnolia Medical Technologies · General Hospital

Nov 2022

Decision

121d

Days

Class 2

Risk

About This 510(k) Submission

K222299 is an FDA 510(k) clearance for the Steripath Micro 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 November 30, 2022, 121 days after receiving the submission on August 1, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number	K222299 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 01, 2022
Decision Date	November 30, 2022
Days to Decision	121 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF