Cleared Traditional

K142344 - DISPOSABLE PASSIVE ACCESSORY FOR MEDTRO...

K142344 is the FDA 510(k) clearance for DISPOSABLE PASSIVE ACCESSORY FOR MEDTRO... by Izi Medical Products, LLC. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K142344 · Izi Medical Products, LLC · Neurology device
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Mar 2015
Decision
210d
Days
Class 2
Risk

K142344 is an FDA 510(k) clearance for the DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Izi Medical Products, LLC (Owings Mills, US). The FDA issued a Cleared decision on March 20, 2015 after a review of 210 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - 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 Izi Medical Products, LLC devices

Submission Details

510(k) Number K142344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2014
Decision Date March 20, 2015
Days to Decision 210 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
62d slower than avg
Panel avg: 148d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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 - HAW Neurological Stereotaxic Instrument

All 218
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K142344.
Leksell Stereotactic System, Injection/ Aspiration Needle Kit
K152558 · Elekta Instrument AB · Mar 2016
Synergy Cranial
K150216 · Medtronic Navigation, Inc. · Jun 2015
STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION
K141833 · Medtronic Navigation, Inc. · Mar 2015
STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM
K133444 · Medtronic Navigation, Inc. · Jul 2014
QUADCUT
K130608 · Medtronic Navigation, Inc. · Aug 2013
SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS
K122211 · Synthes Spine · Dec 2012