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
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.

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 26
Devices cleared under the same product code (HBL) and FDA review panel - the closest regulatory comparables to K955012.
MAYFIELD INFINITY SKULL CLAMP
K051440 · Integra Lifesciences Corp. · Sep 2005
MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104
K050319 · Integra Lifesciences Corp. · Mar 2005
NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX
K031885 · Image-Guided Neurologics, Inc. · Aug 2003
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