HBL · Class II · 21 CFR 882.4460

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

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

51
Total
51
Cleared
128d
Avg days
1982
Since
Stable submission activity - 2 submissions in the last 2 years
Review times increasing: avg 192d recently vs 125d historically

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

51 devices
1–24 of 51
Cleared Oct 27, 2026
DORO® Headrest System for AVA
K262229
Black Forest Medical GmbH
Neurology · 119d
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 Aug 25, 2009
HEAD FIXATION ARC AND TABLE BASE
K091439
Surgivision, Inc.
Radiology · 103d
Cleared Apr 23, 2009
DINKLER SURGICAL SKULL CLAMP, MODEL 0308
K090695
Dinkler Surgical Devices, Inc.
Neurology · 38d
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 Feb 28, 2008
LIMITED ARTIFACT SKULL PIN, MODEL 0107
K073163
Dinkler Surgical Devices, Inc.
Neurology · 111d
Cleared Sep 07, 2007
MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS
K072208
Integra LifeSciences Corporation
Neurology · 30d

About Product Code HBL - Regulatory Context

510(k) Submission Activity

51 total 510(k) submissions under product code HBL since 1982, with 51 receiving FDA clearance (average review time: 128 days).

Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.

FDA 510(k) Review Time - HBL Product Code

Recent submissions under HBL have taken an average of 192 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 →