Cleared Traditional

Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer

K211800 · Quality IN Flow , Ltd. · General Hospital

Dec 2022

Decision

546d

Days

Class 2

Risk

About This 510(k) Submission

K211800 is an FDA 510(k) clearance for the Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer, a Warmer, Thermal, Infusion Fluid (Class II — Special Controls, product code LGZ), submitted by Quality IN Flow , Ltd. (Rosh Ha?Ayin, IL). The FDA issued a Cleared decision on December 8, 2022, 546 days after receiving the submission on June 10, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number	K211800 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 10, 2021
Decision Date	December 08, 2022
Days to Decision	546 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF