LGZ · Class II · 21 CFR 880.5725

FDA Product Code LGZ: Warmer, Thermal, Infusion Fluid

Leading manufacturers include STERIS Corporation, Quality IN Flow , Ltd. and Life Warmer, Inc..

75
Total
75
Cleared
176d
Avg days
1981
Since
Stable submission activity - 3 submissions in the last 2 years
Review times improving: avg 70d recently vs 180d historically

FDA 510(k) Cleared Warmer, Thermal, Infusion Fluid Devices (Product Code LGZ)

75 devices
1–24 of 75
Cleared Apr 24, 2026
°M Warmer System with °M Station
K260988
Mequ A/S
General Hospital · 30d
Cleared Nov 18, 2025
Fluido Compact System
K252636
The Surgical Company International B.V.
General Hospital · 90d
Cleared Sep 04, 2025
Fluido® AirGuard System
K251733
The Surgical Company International BV (As Tsc Life)
General Hospital · 90d
Cleared May 31, 2024
°M Warmer System
K232107
Mequ A/S
General Hospital · 322d
Cleared Jun 05, 2023
Fluido Compact Blood and Fluid Warming System
K211618
The Surgical Company International B.V.
General Hospital · 740d
Cleared Dec 08, 2022
Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer
K211800
Quality IN Flow , Ltd.
General Hospital · 546d
Cleared Aug 12, 2022
ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System
K202461
Smisson-Cartledge Biomedical, LLC
General Hospital · 715d
Cleared May 24, 2022
S-Line
K213191
Barkey GmbH & Co. KG
General Hospital · 237d
Cleared Oct 18, 2019
Quantum Blood and Fluid Warming System
K192325
Life Warmer, Inc.
General Hospital · 52d
Cleared Mar 05, 2019
MAC Medical D-Series Blanket and Solution Warming Cabinets
K180842
Mac Medical, Inc.
General Hospital · 340d
Cleared Jan 28, 2019
Quantum Blood and IV Fluid Infusion Warmer
K181775
Life Warmer, Inc.
General Hospital · 209d
Cleared Apr 27, 2018
QiF Blood and Fluid Warmer
K180154
Quality IN Flow , Ltd.
General Hospital · 98d
Cleared Mar 14, 2012
ENFLOW IV FLUID WARMER
K112902
Vital Signs, Inc.
General Hospital · 162d
Cleared Jul 29, 2011
AMSCO WARMING CABINET
K111870
STERIS Corporation
General Hospital · 28d
Cleared Jun 03, 2011
AMSCO WARMING CABINET
K110769
STERIS Corporation
General Hospital · 77d
Cleared Dec 18, 2009
AMSCO WARMING CABINET
K092823
STERIS Corporation
General Hospital · 95d
Cleared Jun 02, 2008
NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600,
K072080
Smiths Medical Asd, Inc.
General Hospital · 308d
Cleared Oct 24, 2001
COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200
K012832
Nxstage Medical, Inc.
General Hospital · 62d
Cleared Aug 20, 1982
BT 794-BLOOD/FLUID WARMER
K822098
Electromedics, Inc.
General Hospital · 35d

About Product Code LGZ - Regulatory Context

510(k) Submission Activity

75 total 510(k) submissions under product code LGZ since 1981, with 75 receiving FDA clearance (average review time: 176 days).

Submission volume has remained relatively stable over the observed period, with 3 submissions in the last 24 months.

FDA 510(k) Review Time - LGZ Product Code

Recent submissions under LGZ have taken an average of 70 days to reach a decision - down from 180 days historically, suggesting improved FDA processing for this classification.

LGZ devices are reviewed by the General Hospital panel. Browse all General Hospital devices →