Cleared Traditional

K122456 - MRII CRAINIAL DRILL

K122456 is an FDA 510(k) clearance for MRII CRAINIAL DRILL, manufactured by Mri Interventions, Inc.. The device is a Class 2 Neurology device with 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

FDA 510(k) Submission Details - K122456

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
Combination Product No
PCCP Authorized No
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.

HBG Device Classification - Class 2, Special Controls

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)

All 11
Devices cleared under the same product code (HBG) and FDA review panel - the closest regulatory comparables to K122456.
SpineGuard DSG Zavation Screw System
K162884 · Spineguard S.A. · Jan 2017
MRII Cranial Drill and Accessories
K160129 · Mri Interventions, Inc. · Mar 2016
SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm
K151536 · Mri Interventions, Inc. · Jul 2015
FRAMELOCK
K022370 · Medtronic Xomed, Inc. · Oct 2002
CNS INTERCHANGEABLE BIT CRANIAL DRILL
K961113 · Clinical Neuro Systems, LLC · Jun 1996
PS MEDICAL VENTRICULOSTOMY KIT
K915546 · Pudenz-Schulte Medical Research Corp. · Dec 1991