Cleared Traditional

K955012 - MIZUHO RADIOLUCENT HEAD FRAME

K955012 is an FDA 510(k) clearance for MIZUHO RADIOLUCENT HEAD FRAME, manufactured by Mizuho America, Inc.. The device is a Class 2 Neurology device with product code HBL cleared through the Traditional 510(k) pathway after a 316-day FDA review.

K955012 · Mizuho America, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
316d
Days
Class 2
Risk

K955012 is an FDA 510(k) clearance for the MIZUHO RADIOLUCENT HEAD FRAME. Classified as Holder, Head, Neurosurgical (skull Clamp) (product code HBL), Class II - Special Controls.

Submitted by Mizuho America, Inc. (Beverly, US). The FDA issued a Cleared decision on September 12, 1996 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

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

View all Mizuho America, Inc. devices

FDA 510(k) Submission Details - K955012

510(k) Number K955012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1995
Decision Date September 12, 1996
Days to Decision 316 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
167d slower than avg
Panel avg: 149d · This submission: 316d
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 46
Devices cleared under the same product code (HBL) and FDA review panel - the closest regulatory comparables to K955012.
VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000
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MAYFIELD RADIOLUCENT 2000 SKULL CLAMP
K953124 · Ohio Medical Instrument Co., Inc. · Feb 1996
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K941558 · Ohio Medical Instrument Co., Inc. · Dec 1995
MAYFIELD RADIOLUCENT SKULL CLAMP
K934289 · Ohio Medical Instrument Co., Inc. · Jan 1994