Cleared Special

K120979 - CAREFUSION NICOLET EDX

K120979 is an FDA 510(k) clearance for CAREFUSION NICOLET EDX, manufactured by Carefusion 209, Inc.. The device is a Class 2 Neurology device with product code GWF cleared through the Special 510(k) pathway after a 23-day FDA review.

K120979 · Carefusion 209, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
23d
Days
Class 2
Risk

K120979 is an FDA 510(k) clearance for the CAREFUSION NICOLET EDX. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Carefusion 209, Inc. (Middleton, US). The FDA issued a Cleared decision on April 25, 2012 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1870 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K120979

510(k) Number K120979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2012
Decision Date April 25, 2012
Days to Decision 23 days
Submission Type Special
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
126d faster than avg
Panel avg: 149d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

GWF Device Classification - Class 2, Special Controls

Product Code GWF Stimulator, Electrical, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1870
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 - GWF Stimulator, Electrical, Evoked Response

All 123
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K120979.
SYNERGY FOCUS DESKTOP VERSION
K130346 · Natus Neurology Incorporated · May 2013
MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM
K120397 · Nihon Kohden Corp. · Sep 2012
NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)
K112881 · Nexstim OY · May 2012
CAREFUSION NICOLET EDX
K112052 · Carefusion 209, Inc. · Mar 2012
C2 NERVEMONITOR SYSTEM WITH ACCESSORIES
K111647 · Inomed Medizintechnik GmbH · Oct 2011
NEUROVISION NERVE LOCATOR MONITOR
K110140 · Neurovision Medical Products, Inc. · Sep 2011
K120979 · CAREFUSION NICOLET EDX
Download PDF FDA Summary Carefusion 209, Inc.