FDA Product Code BRZ: Set, Blood Transfusion
Leading manufacturers include Baxter Healthcare Corporation.
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
Cleared
Nov 17, 2022
Blood Administration Sets
Baxter Healthcare Corporation
General Hospital
262d
Cleared
Jun 10, 2021
Blood Administration Set
Baxter Healthcare Corporation
General Hospital
125d
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.
BRZ devices are reviewed by the General Hospital panel. Browse all General Hospital devices →