Cleared Traditional

K171186 - Cerebrotech CMS-5000 (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K171186 · Cerebrotech Medical Systems · Neurology device
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Dec 2017
Decision
228d
Days
Class 2
Risk

K171186 is an FDA 510(k) clearance for the Cerebrotech CMS-5000. Classified as Impedance Plethysmograph, Cranial (product code QAF), Class II - Special Controls.

Submitted by Cerebrotech Medical Systems (Pleasanton, US). The FDA issued a Cleared decision on December 8, 2017 after a review of 228 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.2770 - 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.

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Submission Details

510(k) Number K171186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2017
Decision Date December 08, 2017
Days to Decision 228 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
80d slower than avg
Panel avg: 148d · This submission: 228d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QAF Impedance Plethysmograph, Cranial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2770
Definition Detect Or Measure Variations In Volume In The Cranium, Using Tissue Impedance Properties.
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.