FDA Product Code QBV:
Leading manufacturers include Miracell Co., Ltd..
2
Total
2
Cleared
405d
Avg days
2026
Since
Growing category -
2 submissions in the last 2 years
vs 0 in the prior period
FDA 510(k) Cleared QBV Devices (Product Code QBV)
2 devices
Cleared
Apr 02, 2026
SMART M-CELL PRP Concentration System
Miracell Co., Ltd.
Hematology
405d
Cleared
Apr 02, 2026
SMART M-CELL Bone Marrow Concentration System
Miracell Co., Ltd.
Hematology
405d
About Product Code QBV - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QBV since 2026, with 2 receiving FDA clearance (average review time: 405 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
QBV devices are reviewed by the Hematology panel. Browse all Hematology devices →