LGZ · Class II · 21 CFR 880.5725

FDA Product Code LGZ: Warmer, Thermal, Infusion Fluid

Leading manufacturers include Belmont Instrument Corp., Quality IN Flow , Ltd. and STERIS Corporation.

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 Sep 27, 2017
QiF Blood and Fluid Warmer
K171215
Quality IN Flow , Ltd.
General Hospital · 155d
Cleared Apr 20, 2017
QiF Blood and Fluid Warmer
K163708
Quality IN Flow , Ltd.
General Hospital · 112d
Cleared Dec 28, 2016
Hang&Go PAC
K161613
Rand S.R.L.
General Hospital · 201d
Cleared Jun 23, 2016
QiF Blood and Fluid Warmer
K150404
Quality IN Flow , Ltd.
General Hospital · 491d
Cleared Sep 02, 2015
The Belmont Hyperthermia Pump
K152208
Belmont Instrument Corporation
General Hospital · 26d
Cleared Jul 09, 2015
Penguin In-Line Warmer
K150484
Creche Innovations
General Hospital · 135d
Cleared Dec 06, 2013
DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET
K132202
Enthermics Medical Systems, Inc.
General Hospital · 143d
Cleared Nov 06, 2013
BELMONT HYPERTHERMIA PUMP
K131519
Belmont Instrument Corp.
General Hospital · 162d
Cleared Oct 03, 2013
NATUS WARMETTE BLANKET AND DUAL CABINETS
K132110
Natus Nicolet Ireland, Ltd.
General Hospital · 86d
Cleared Jun 14, 2013
ENFLOW IV FLUID WARMER INSULATED STRAP
K130867
Vital Signs, Inc., A GE Healthcare Company
General Hospital · 78d
Cleared Jun 13, 2013
ENTERAL NUTRITION WARMER
K122449
Acacia, Inc.
General Hospital · 304d
Cleared Nov 28, 2012
ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER
K121775
Vital Signs, Inc., A GE Healthcare Company
General Hospital · 163d

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 →