Cleared Traditional

Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)

K251676 · Microtek Medical, LLC · General Hospital

Sep 2025

Decision

109d

Days

Class 2

Risk

About This 510(k) Submission

K251676 is an FDA 510(k) clearance for the Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S), a Set, I.v. Fluid Transfer (Class II — Special Controls, product code LHI), submitted by Microtek Medical, LLC (Nortfield, US). The FDA issued a Cleared decision on September 16, 2025, 109 days after receiving the submission on May 30, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K251676 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 30, 2025
Decision Date	September 16, 2025
Days to Decision	109 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF