Cleared Traditional

K083371 - NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP)

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

K083371 · Natus Medical, Inc. · Neurology device
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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

FDA 510(k) Submission Details - K083371

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.

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 97
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