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

FDA 510(k) K211800 · Quality IN Flow , Ltd.

Substantially Equivalent

510(k) numberK211800

Submission

Device name
Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer
Applicant
Quality IN Flow , Ltd.
Rosh Ha’Ayin, IL
Received
June 10, 2021
Decision date
December 8, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LGZ – Warmer, Thermal, Infusion Fluid
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5725
Specialty
General Hospital

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K180842MAC Medical D-Series Blanket and Solution Warming CabinetsLGZ · Traditional Mac Medical, Inc.03/05/2019SE
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More from Life Warmer, Inc.

510(k)DeviceDecision
K180154QiF Blood and Fluid WarmerLGZ · Special 04/27/2018SE
K171215QiF Blood and Fluid WarmerLGZ · Traditional 09/27/2017SE
K163708QiF Blood and Fluid WarmerLGZ · Special 04/20/2017SE
K150404QiF Blood and Fluid WarmerLGZ · Traditional 06/23/2016SE

Questions and answers

When was Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer cleared by the FDA?

Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer (K211800) received a 510(k) decision of Substantially Equivalent on December 8, 2022, 546 days after the submission was received.

What is the product code of K211800?

The FDA product code is LGZ – Warmer, Thermal, Infusion Fluid, a Class II (moderate risk) device regulated under 21 CFR 880.5725.