Cleared Traditional

K082886 - ZOOM-100DC

K082886 is an FDA 510(k) clearance for ZOOM-100DC, manufactured by Brainscope Company, Inc.. The device is a Class 2 Neurology device with product code OLT cleared through the Traditional 510(k) pathway after a 314-day FDA review.

K082886 · Brainscope Company, Inc. · Neurology device
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Aug 2009
Decision
314d
Days
Class 2
Risk

K082886 is an FDA 510(k) clearance for the ZOOM-100DC. Classified as Non-normalizing Quantitative Electroencephalograph Software (product code OLT), Class II - Special Controls.

Submitted by Brainscope Company, Inc. (Washington, US). The FDA issued a Cleared decision on August 10, 2009 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - 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 Brainscope Company, Inc. devices

FDA 510(k) Submission Details - K082886

510(k) Number K082886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2008
Decision Date August 10, 2009
Days to Decision 314 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
166d slower than avg
Panel avg: 148d · This submission: 314d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLT Device Classification - Class 2, Special Controls

Product Code OLT Non-normalizing Quantitative Electroencephalograph Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Analyze Electroencephalograph Data Using Conventional Methodology To Output And Display Standard Electroencephalograph Parameters For Interpretation By A Qualified User.
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.

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All 34
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