HBB · Class II · 21 CFR 882.4370

FDA Product Code HBB: Motor, Drill, Pneumatic

Leading manufacturers include Midas Rex Pneumatic Tools, Inc., The Anspach Effort, Inc. and Aesculap, Inc..

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
Cleared Nov 09, 2018
ELAN 4 Air Motor System
K172907
Aesculap, Inc.
Neurology · 410d
Cleared Mar 23, 2017
Medtronic Legend Pneumatic
K163182
Medtronic Powered Surgical Solutions
Neurology · 129d
Cleared May 22, 2015
Stryker Maestro Air Motors
K150801
Stryker Corporation
Neurology · 57d
Cleared Aug 24, 2010
LEGEND POWER ADAPTER MODEL: 6475000
K101168
Medtronic Sofamor Danek
Neurology · 120d
Cleared Apr 14, 2010
SYNTHES AIR PEN DRIVE (APD) SYSTEM
K093361
Synthes (Usa)
Neurology · 168d
Cleared Jan 26, 2007
ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM
K061297
The Anspach Effort, Inc.
Neurology · 262d
Cleared Oct 26, 2006
STRYKER ARIA PNEUMATIC SYSTEM
K061725
Stryker Instruments
Neurology · 129d
Cleared Jan 13, 2005
MEDICON VIPAIR HIGH SPEED SYSTEM
K042974
Medicon EG
Neurology · 77d
Cleared Sep 07, 2004
STRYKER MAESTRO SYSTEM
K041754
Stryker Corp.
Neurology · 70d
Cleared Apr 15, 2004
ANSPACH MRI SAFE SURGICAL DRILL SYSTEM
K040186
The Anspach Effort, Inc.
Neurology · 79d
Cleared Apr 20, 2000
CRANIAL DRILL
K000195
Image-Guided Neurologics, Inc.
Neurology · 90d
Cleared Dec 27, 1999
SODEM PERFORATOR DRIVE
K993851
Sodemsystems
Neurology · 45d
Cleared Dec 21, 1999
MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE
K994175
Sodemsystems
Neurology · 11d
Cleared Jul 30, 1999
KOMET XK-95 PERFORATOR MOTOR (MI-102)
K991625
Komet Medical
Neurology · 80d
Cleared Nov 06, 1998
TRITON HUDSON CHUCK ATTACHMENT
K983092
Mednext, Inc.
Neurology · 64d
Cleared Sep 02, 1998
AESCULAP HILAN MOTOR SYSTEM
K980686
Aesculap, Inc.
Neurology · 191d
Cleared Sep 12, 1997
MIDAS REX MOTOR
K972289
Midas Rex Pneumatic Tools, Inc.
Neurology · 85d
Cleared Jan 22, 1997
SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY
K954717
Sodem Diffusion SA
Neurology · 467d
Cleared Nov 19, 1996
ANSPAHC SPEED REDUCER
K960630
The Anspach Effort, Inc.
Neurology · 284d
Cleared Nov 19, 1996
MIDAS REX III MOTOR
K962483
Midas Rex Pneumatic Tools, Inc.
Neurology · 146d
Cleared May 16, 1996
MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS)
K953434
Midas Rex Pneumatic Tools, Inc.
Neurology · 300d
Cleared Oct 13, 1989
MICROMEDICS SURGICAL DRILL SYSTEM
K895739
Micromedics, Inc.
Neurology · 17d

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 510(k) Review Time - HBB Product Code

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 →