HBB · Class II · 21 CFR 882.4370

FDA Product Code HBB: Motor, Drill, Pneumatic

Leading manufacturers include Adeor Medical AG.

27
Total
27
Cleared
138d
Avg days
1989
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 100d recently vs 139d historically

FDA 510(k) Cleared Motor, Drill, Pneumatic Devices (Product Code HBB)

27 devices
1–24 of 27
Cleared Mar 06, 2026
Velocity Alpha MR High Speed Surgical Drill System
K253772
Adeor Medical AG
Neurology · 100d

About Product Code HBB - Regulatory Context

510(k) Submission Activity

27 total 510(k) submissions under product code HBB since 1989, with 27 receiving FDA clearance (average review time: 138 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under HBB have taken an average of 100 days to reach a decision - down from 139 days historically, suggesting improved FDA processing for this classification.

HBB devices are reviewed by the Neurology panel. Browse all Neurology devices →