Cleared Traditional

K112052 - CAREFUSION NICOLET EDX

K112052 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 Traditional 510(k) pathway after a 241-day FDA review.

K112052 · Carefusion 209, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
241d
Days
Class 2
Risk

K112052 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 March 15, 2012 after a review of 241 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1870 - 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.

FDA 510(k) Submission Details - K112052

510(k) Number K112052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2011
Decision Date March 15, 2012
Days to Decision 241 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
92d slower than avg
Panel avg: 149d · This submission: 241d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K112052.
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
K120979 · Carefusion 209, Inc. · Apr 2012
C2 NERVEMONITOR SYSTEM WITH ACCESSORIES
K111647 · Inomed Medizintechnik GmbH · Oct 2011
NEUROVISION NERVE LOCATOR MONITOR
K110140 · Neurovision Medical Products, Inc. · Sep 2011
PROTEKTOR 32
K093304 · Natus Medical, Inc. · Aug 2010
K112052 · CAREFUSION NICOLET EDX
Download PDF FDA Summary Carefusion 209, Inc.