BRZ · Class II · 21 CFR 880.5440

FDA Product Code BRZ: Set, Blood Transfusion

Leading manufacturers include Puritas Health Care, Inc., Baxter Healthcare Corporation and Vygon Corp..

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 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 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 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 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.