Cleared Traditional

K122456 - MRII CRAINIAL DRILL

K122456 is the FDA 510(k) clearance for MRII CRAINIAL DRILL by Mri Interventions, Inc.. It is a Class 2 Neurology device (product code HBG) cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K122456 · Mri Interventions, Inc. · Neurology device
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Mar 2013
Decision
221d
Days
Class 2
Risk

K122456 is an FDA 510(k) clearance for the MRII CRAINIAL DRILL. Classified as Drills, Burrs, Trephines & Accessories (manual) (product code HBG), Class II - Special Controls.

Submitted by Mri Interventions, Inc. (Irvine, US). The FDA issued a Cleared decision on March 22, 2013 after a review of 221 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4300 - 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.

View all Mri Interventions, Inc. devices

Submission Details

510(k) Number K122456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2012
Decision Date March 22, 2013
Days to Decision 221 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
73d slower than avg
Panel avg: 148d · This submission: 221d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HBG Drills, Burrs, Trephines & Accessories (manual)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4300
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 - HBG Drills, Burrs, Trephines & Accessories (manual)

Devices cleared under the same product code (HBG) and FDA review panel - the closest regulatory comparables to K122456.
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