Cleared Traditional

K953124 - MAYFIELD RADIOLUCENT 2000 SKULL CLAMP

K953124 is an FDA 510(k) clearance for MAYFIELD RADIOLUCENT 2000 SKULL CLAMP, manufactured by Ohio Medical Instrument Co., Inc.. The device is a Class 2 Neurology device with product code HBL cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K953124 · Ohio Medical Instrument Co., Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
219d
Days
Class 2
Risk

K953124 is an FDA 510(k) clearance for the MAYFIELD RADIOLUCENT 2000 SKULL CLAMP. Classified as Holder, Head, Neurosurgical (skull Clamp) (product code HBL), Class II - Special Controls.

Submitted by Ohio Medical Instrument Co., Inc. (Cincinnati, US). The FDA issued a Cleared decision on February 9, 1996 after a review of 219 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4460 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K953124

510(k) Number K953124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1995
Decision Date February 09, 1996
Days to Decision 219 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 149d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBL Device Classification - Class 2, Special Controls

Product Code HBL Holder, Head, Neurosurgical (skull Clamp)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4460
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - HBL Holder, Head, Neurosurgical (skull Clamp)

All 47
Devices cleared under the same product code (HBL) and FDA review panel - the closest regulatory comparables to K953124.
PSI SKULL CLAMP
K002276 · V. Mueller Neuro/Spine · Aug 2000
DORO HEADREST SYSTEM
K001808 · Pro-Med Instruments GmbH · Aug 2000
MIZUHO RADIOLUCENT HEAD FRAME
K955012 · Mizuho America, Inc. · Sep 1996
MAYFIELD CHILD DISPOSABLE SKULL PIN
K941558 · Ohio Medical Instrument Co., Inc. · Dec 1995
MAYFIELD RADIOLUCENT SKULL CLAMP
K934289 · Ohio Medical Instrument Co., Inc. · Jan 1994
MAYFIELD* A-2000 SKULL CLAMP
K932807 · Ohio Medical Instrument Co., Inc. · Sep 1993
K953124 · MAYFIELD RADIOLUCENT 2000 SKULL CLAMP
Download PDF FDA Summary Ohio Medical Instrume…