BRZClass II

Set, Blood Transfusion

21 CFR 880.5440 / General Hospital

BRZ is the FDA product code for Set, Blood Transfusion, a class II device type, regulated under 21 CFR 880.5440. As of 2026-09-10, FDA records hold 30 510(k) clearances under this code, the most recent dated 2022-11-17, and 24 recalls.

Classification record

Product code: BRZ
Device name: Set, Blood Transfusion
Regulation: 21 CFR 880.5440
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: Yes
Ingested clearances: 30
Ingested recalls: 24

Clearances, product code BRZ

By decision year

30 clearances under product code BRZ with a decision year between 1982 and 2022, 1984 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code BRZ by decision year
Year	Clearances
1982	2
1983	1
1984	3
1985	3
1986	2
1987	2
1988	1
1992	2
1994	2
1997	1
1999	1
2000	1
2002	1
2005	3
2008	1
2009	1
2013	1
2021	1
2022	1

Applicants with the most clearances

Product code BRZ

Applicants holding the most 510(k) clearances under product code BRZ
Applicant	Clearances
Baxter Healthcare Corporation	3
Puritas Health Care, Inc.	2
The Boston Medical Group	2
Alpha Therapeutic Corp.	1
Amkor Trading Co.	1
Arteriocyte Medical Systems, Inc.	1
Blood Products Specialties, LLC	1
Cardinal Health, Alaris Products	1
Charter Medical, LLC	1
Churchill Corp.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 23 companies shown, in name order