Cleared Traditional

K083371 - NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK

K083371 is the FDA 510(k) clearance for NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK by Natus Medical, Inc.. It is a Class 2 Neurology device (product code GWF) cleared through the Traditional 510(k) pathway after a 389-day FDA review.

K083371 · Natus Medical, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
389d
Days
Class 2
Risk

K083371 is an FDA 510(k) clearance for the NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP). Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Natus Medical, Inc. (Mudelein, US). The FDA issued a Cleared decision on December 8, 2009 after a review of 389 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Natus Medical, Inc. devices

Submission Details

510(k) Number K083371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2008
Decision Date December 08, 2009
Days to Decision 389 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
241d slower than avg
Panel avg: 148d · This submission: 389d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 51
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K083371.
NIM Vital, Nerve Integrity Monitor
K200759 · Medtronic Xomed, Inc. · Oct 2020
The EPAD 2 System
K182542 · Safeop Surgical, Inc. · Feb 2019
MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE
K094054 · Nuvasive, Inc. · May 2010
NUVASIVE NEURO VISION SYSTEM
K090298 · Nuvasive, Inc. · Jun 2009
NIM 3.0
K083124 · Medtronic Xomed, Inc. · Feb 2009
SEN-4100 ELECTRIC STIMULATOR
K071969 · Nihon Kohden America, Inc. · Oct 2008