HBL · Class II · 21 CFR 882.4460

FDA Product Code HBL: Holder, Head, Neurosurgical (skull Clamp)

Leading manufacturers include Ohio Medical Instrument Co., Inc., Integra LifeSciences Corporation and Pro-Med Instruments GmbH.

50
Total
50
Cleared
128d
Avg days
1982
Since
Declining activity - 1 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 265d recently vs 125d historically

FDA 510(k) Cleared Holder, Head, Neurosurgical (skull Clamp) Devices (Product Code HBL)

50 devices
1–24 of 50
Cleared Nov 06, 2025
mb-FIX Cranial Stabilization Systems
K250423
Medical Bees GmbH
Neurology · 265d
Cleared Jul 26, 2024
DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00)
K241883
Pro-Med Instruments GmbH
Neurology · 28d
Cleared Apr 24, 2024
DORO LUCENT Skull Clamp (1101.001)
K240319
Pro-Med Instruments GmbH
Neurology · 82d
Cleared Mar 29, 2021
DORO QR3 Headrest System (Aluminum)
K203505
Pro-Med Instruments GmbH
Neurology · 119d
Cleared Jun 02, 2020
DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)
K193438
Pro-Med Instruments GmbH
Neurology · 174d
Cleared Feb 21, 2020
DORO LUCENT® iXI and iMRI Headrest System
K191740
Pro-Med Instruments GmbH
Neurology · 235d
Cleared Nov 15, 2019
Arcus Head Fixation Frame
K191701
Mri Interventions, Inc.
Neurology · 143d
Cleared Oct 22, 2019
DORO QR3 XTom Headholder System
K191979
Pro-Med Instruments GmbH
Neurology · 90d
Cleared Feb 23, 2017
TZ SKULL PIN Adult
K163322
Tz Medical, Inc.
Neurology · 90d
Cleared Nov 24, 2014
MAYFIELD Skull Clamp
K142238
Integra LifeSciences Corporation
Neurology · 103d
Cleared Sep 04, 2014
HFD100 ROCKER ARM ACCESSORY
K141950
Imris, Inc.
Neurology · 48d
Cleared Apr 26, 2013
STERILE RADIOLUCENT SKULL PINS
K122225
Brainlab AG
Neurology · 275d
Cleared Apr 23, 2013
MAYFIELD INFINITY XR2 SKULL CLAMP
K130389
Integra LifeSciences Corporation
Neurology · 67d
Cleared May 24, 2012
MAYFIELD SKULL CLAMP
K120633
Integra LifeSciences Corporation
Neurology · 84d
Cleared Mar 23, 2012
IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)
K113748
Imris, Inc.
Radiology · 93d
Cleared Mar 11, 2011
HEAD FIATION DEVICE (HFD 100)
K103493
Imris, Inc.
Neurology · 102d
Cleared Mar 10, 2010
FIXIT HEADREST CLAMP SYSTEM
K083803
Medicon EG
Neurology · 443d
Cleared Apr 20, 2009
MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114
K090506
Integra LifeSciences Corporation
Neurology · 54d
Cleared Oct 08, 2008
MAYFIELD MR/X-RAY SKULL CLAMP
K081401
Integra Lifesciences Corp.
Neurology · 142d
Cleared Sep 07, 2007
MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS
K072208
Integra LifeSciences Corporation
Neurology · 30d
Cleared Jun 13, 2007
MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS
K071458
Integra LifeSciences Corporation
Neurology · 19d
Cleared Nov 21, 2005
MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
K053045
Integra LifeSciences Corporation
Neurology · 24d
Cleared Sep 20, 2005
MAYFIELD INFINITY SKULL CLAMP
K051440
Integra Lifesciences Corp.
Neurology · 110d
Cleared Mar 31, 2005
MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104
K050319
Integra Lifesciences Corp.
Neurology · 50d

About Product Code HBL - Regulatory Context

510(k) Submission Activity

50 total 510(k) submissions under product code HBL since 1982, with 50 receiving FDA clearance (average review time: 128 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.

FDA 510(k) Review Time - HBL Product Code

Recent submissions under HBL have taken an average of 265 days to reach a decision - up from 125 days historically. Manufacturers should account for longer review timelines in current project planning.

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