BRZ · Class II · 21 CFR 880.5440

FDA Product Code BRZ: Set, Blood Transfusion

Leading manufacturers include Baxter Healthcare Corporation, Puritas Health Care, Inc. and The Boston Medical Group.

30
Total
30
Cleared
102d
Avg days
1982
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Set, Blood Transfusion Devices (Product Code BRZ)

30 devices
1–24 of 30
Cleared Nov 17, 2022
Blood Administration Sets
K220558
Baxter Healthcare Corporation
General Hospital · 262d
Cleared Jun 10, 2021
Blood Administration Set
K210335
Baxter Healthcare Corporation
General Hospital · 125d
Cleared Oct 04, 2013
200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER
K132905
Arteriocyte Medical Systems, Inc.
General Hospital · 18d
Cleared Apr 10, 2009
BLOOD TRANSFUSION SET
K083349
Shan Dong Wei Gao Group Medical Polymer Products
General Hospital · 148d
Cleared Mar 03, 2008
BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR
K073339
Fenwal, Inc.
General Hospital · 96d
Cleared Jun 30, 2005
PENTATRASFU BLOOD TRANSFUSION SETS
K041496
Pentaferte S.P.A
General Hospital · 391d
Cleared Jun 20, 2005
30 ML OR 60 ML PEDI-SYRINGE FILTER
K050805
Blood Products Specialties, LLC
General Hospital · 82d
Cleared Apr 01, 2005
BLOOD HAND PUMP ADMINISTRATION SET
K050115
Cardinal Health, Alaris Products
General Hospital · 73d
Cleared Nov 07, 2002
BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015
K023039
Tuta Healthcare Pty Limited
General Hospital · 56d
Cleared Aug 15, 2000
CHARTER MEDICAL NEONATAL SYRINGE SET
K000685
Charter Medical, Ltd.
General Hospital · 168d
Cleared Nov 17, 1999
MODIFIED BLOOD RECIPIENT SET
K993120
Baxter Healthcare Corp
General Hospital · 58d
Cleared Dec 16, 1997
PROTOS BLOOD TRANSFUSION SET
K972843
Globe Ent., Inc.
General Hospital · 137d
Cleared Apr 21, 1994
Y-TYPE BLOOD ADMINISTRATION SET
K940074
Puritas Health Care, Inc.
General Hospital · 105d
Cleared Apr 15, 1994
MULTISET
K940055
Puritas Health Care, Inc.
General Hospital · 100d
Cleared Dec 24, 1992
Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2
K921595
Haemotronic, Inc.
General Hospital · 265d
Cleared Jun 04, 1992
BLOOD ADMINISTRATION SET
K920788
Douglas Medical Products Corp.
General Hospital · 105d
Cleared Feb 16, 1988
JMS TRANSFUSION SET
K880174
Jms Co., Ltd.
General Hospital · 32d
Cleared Jul 27, 1987
IV ADMINISTRATION SET
K871908
Travenol Laboratories, S.A.
General Hospital · 73d
Cleared Jan 20, 1987
CHURCHILL BLOOD ADMINISTRATION SET
K864441
Churchill Corp.
General Hospital · 69d
Cleared May 27, 1986
STANDARD BLOOD TRANSFUSION FILTER SET (CODE 1025)
K861523
Jufrey Multimed Corp.
General Hospital · 34d
Cleared Jan 09, 1986
CONNECTOR, BLOOD TUBING, INFUSION T. INTRAVENOUS I
K854562
Medelec Intl. Corp.
General Hospital · 56d
Cleared Nov 18, 1985
ISOVOL-EXCHANGE TRAY
K852167
Rocky Mountain Medical Corp.
General Hospital · 182d
Cleared Aug 22, 1985
MULTISET 40
K853386
Migada, Ltd.
General Hospital · 10d
Cleared May 03, 1985
VYGON EXCHANGE TRANSFUSION TRAY 275.00
K851477
Vygon Corp.
General Hospital · 18d

About Product Code BRZ - Regulatory Context

510(k) Submission Activity

30 total 510(k) submissions under product code BRZ since 1982, with 30 receiving FDA clearance (average review time: 102 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.