BZRClass II

Mixer, Breathing Gases, Anesthesia Inhalation

21 CFR 868.5330 / Anesthesiology

BZR is the FDA product code for Mixer, Breathing Gases, Anesthesia Inhalation, a class II device type, regulated under 21 CFR 868.5330. As of 2026-09-10, FDA records hold 55 510(k) clearances under this code, the most recent dated 2025-07-14, and 3 recalls.

Classification record

Product code: BZR
Device name: Mixer, Breathing Gases, Anesthesia Inhalation
Regulation: 21 CFR 868.5330
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: Yes
Ingested clearances: 55
Ingested recalls: 3

Clearances, product code BZR

By decision year

55 clearances under product code BZR with a decision year between 1976 and 2025, 1980 the highest year at 5.

Show the numbers

510(k) clearances under FDA product code BZR by decision year
Year	Clearances
1976	2
1980	5
1981	1
1984	1
1985	1
1986	2
1987	1
1988	1
1989	1
1990	2
1991	1
1993	4
1995	4
1996	1
1998	2
1999	2
2000	1
2003	2
2004	1
2005	2
2006	1
2008	1
2009	1
2010	1
2011	2
2012	2
2015	1
2016	1
2018	1
2021	1
2023	4
2024	1
2025	1

Applicants with the most clearances

Product code BZR

Applicants holding the most 510(k) clearances under product code BZR
Applicant	Clearances
Bird Products Corp.	5
Sk Med	4
Maxtec, LLC	3
Baldus Sedation GmbH & Co. KG	2
Hamilton Medical AG	2
O-Two Medical Technologies, Inc.	2
Parker Hannifin Corp.	2
Precision Medical, Inc.	2
Sechrist Industries Inc	2
Siemens Elema AB	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 35 companies shown, in name order