LGZClass II

Warmer, Thermal, Infusion Fluid

21 CFR 880.5725 / General Hospital

LGZ is the FDA product code for Warmer, Thermal, Infusion Fluid, a class II device type, regulated under 21 CFR 880.5725. As of 2026-09-10, FDA records hold 75 510(k) clearances under this code, the most recent dated 2026-04-24, and 33 recalls.

Classification record

Product code: LGZ
Device name: Warmer, Thermal, Infusion Fluid
Regulation: 21 CFR 880.5725
Device class: Class II
Review panel: General Hospital
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 76
Ingested recalls: 33

Clearances, product code LGZ

By decision year

76 clearances under product code LGZ with a decision year between 1981 and 2026, 2012 the highest year at 7.

Show the numbers

510(k) clearances under FDA product code LGZ by decision year
Year	Clearances
1981	2
1982	1
1988	1
1989	1
1990	2
1991	1
1992	3
1993	1
1996	2
1998	3
2000	1
2001	4
2003	5
2005	1
2006	4
2007	2
2008	4
2009	2
2010	2
2011	3
2012	7
2013	5
2015	2
2016	2
2017	2
2018	1
2019	3
2022	3
2023	1
2024	1
2025	2
2026	2

Applicants with the most clearances

Product code LGZ

Applicants holding the most 510(k) clearances under product code LGZ
Applicant	Clearances
Belmont Medical Technologies	6
Quality in Flow Ltd.	5
C.F. Electronics, Inc.	3
Medical Solutions, Inc.	3
STERIS Corporation	3
Arizant Healthcare, Inc.	2
Automatic Medical Technologies, Inc.	2
Datachem, Inc.	2
Elltec Co., Ltd.	2
Enthermics Medical Systems, Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 62 companies shown, in name order