BSZClass II

Gas-Machine, Anesthesia

21 CFR 868.5160 / Anesthesiology

BSZ is the FDA product code for Gas-Machine, Anesthesia, a class II device type, regulated under 21 CFR 868.5160. As of 2026-09-10, FDA records hold 189 510(k) clearances under this code, the most recent dated 2026-06-25, and 173 recalls.

Classification record

Product code: BSZ
Device name: Gas-Machine, Anesthesia
Regulation: 21 CFR 868.5160
Device class: Class II
Review panel: Anesthesiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: Yes
GMP exempt: No
Third party review eligible: No
Ingested clearances: 189
Ingested recalls: 177

Clearances, product code BSZ

By decision year

189 clearances under product code BSZ with a decision year between 1976 and 2026, 2004 the highest year at 11.

Show the numbers

510(k) clearances under FDA product code BSZ by decision year
Year	Clearances
1976	1
1977	4
1978	1
1979	2
1980	5
1981	1
1982	1
1983	7
1984	4
1985	9
1986	5
1987	6
1988	3
1989	5
1990	8
1991	3
1992	2
1993	5
1994	5
1995	2
1996	1
1997	8
1998	7
1999	4
2000	7
2001	6
2002	2
2003	2
2004	11
2005	6
2006	4
2007	3
2008	8
2009	3
2010	1
2011	6
2012	5
2013	5
2014	4
2015	4
2016	1
2017	3
2018	2
2020	1
2021	1
2023	2
2025	1
2026	2

Applicants with the most clearances

Product code BSZ

Applicants holding the most 510(k) clearances under product code BSZ
Applicant	Clearances
GE Healthcare	43
Draeger, Inc.	35
Shenzhen Mindray Bio-Medical Electronics Co.,LTD	6
GE Healthcare Finland Oy	5
Maquet Critical Care AB	5
Narco Mckesson Co.	5
Ohio Medical Products	5
Blease Medical Equipment, Ltd.	4
Datex Division Instrumentarium Corp.	4
American Anesthesia, Inc.	3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 29 companies shown, in name order