Cleared Traditional

K093304 - PROTEKTOR 32

K093304 is an FDA 510(k) clearance for PROTEKTOR 32, 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 294-day FDA review.

K093304 · Natus Medical, Inc. · Neurology device
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Aug 2010
Decision
294d
Days
Class 2
Risk

K093304 is an FDA 510(k) clearance for the PROTEKTOR 32. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Natus Medical, Inc. (Oakville, CA). The FDA issued a Cleared decision on August 11, 2010 after a review of 294 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.

View all Natus Medical, Inc. devices

FDA 510(k) Submission Details - K093304

510(k) Number K093304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2009
Decision Date August 11, 2010
Days to Decision 294 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 148d · This submission: 294d
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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