Cleared Traditional

MIZUHO RADIOLUCENT HEAD FRAME (K955012) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
168d slower than avg
Panel avg: 148d · This submission: 316d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 14
Devices cleared under the same product code (HBL) and FDA review panel - the closest regulatory comparables to K955012.
Arcus Head Fixation Frame
K191701 · Mri Interventions, Inc. · Nov 2019
DORO QR3 XTom Headholder System
K191979 · Pro-Med Instruments GmbH · Oct 2019
STERILE RADIOLUCENT SKULL PINS
K122225 · Brainlab AG · Apr 2013
CODMAN SKULL PINS (ADULT & CHILD), REUSABLE
K912005 · Codman & Shurtleff, Inc. · Sep 1991
CODMAN DISPOSABLE SKULL PINS
K911723 · Codman & Shurtleff, Inc. · Sep 1991
CODMAN SKULL CLAMP
K913170 · Codman & Shurtleff, Inc. · Sep 1991