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LGZ — Warmer, Thermal, Infusion Fluid Class II

FDA Device Classification

Classification Details

Product Code
LGZ
Device Class
Class II
Regulation Number
880.5725
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252636surgical company internationalFluido Compact SystemNovember 18, 2025
K251733surgical company international bv (as tsc life)Fluido® AirGuard SystemSeptember 4, 2025
K232107mequ°M Warmer SystemMay 31, 2024
K211618surgical company internationalFluido Compact Blood and Fluid Warming SystemJune 5, 2023
K211800quality in flowWarrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior December 8, 2022
K202461smisson-cartledge biomedicalThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion SysAugust 12, 2022
K213191barkey gmbh and co. kgS-LineMay 24, 2022
K192325life warmerQuantum Blood and Fluid Warming SystemOctober 18, 2019
K180842mac medicalMAC Medical D-Series Blanket and Solution Warming CabinetsMarch 5, 2019
K181775life warmerQuantum Blood and IV Fluid Infusion WarmerJanuary 28, 2019
K180154quality in flowQiF Blood and Fluid WarmerApril 27, 2018
K171215quality in flowQiF Blood and Fluid WarmerSeptember 27, 2017
K163708quality in flowQiF Blood and Fluid WarmerApril 20, 2017
K161613randHang&Go PACDecember 28, 2016
K150404quality in flowQiF Blood and Fluid WarmerJune 23, 2016
K152208belmont instrument corporationThe Belmont Hyperthermia PumpSeptember 2, 2015
K150484creche innovationsPenguin In-Line WarmerJuly 9, 2015
K132202enthermics medical systemsDC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINETDecember 6, 2013
K131519belmont instrumentBELMONT HYPERTHERMIA PUMPNovember 6, 2013
K132110natus nicolet irelandNATUS WARMETTE BLANKET AND DUAL CABINETSOctober 3, 2013