Cleared Traditional

K000565 - MODIFICATION TO NC-STAT (FDA 510(k) Clearance)

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

K000565 · Neurometrix, Inc. · Neurology device
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Jun 2000
Decision
126d
Days
Class 2
Risk

K000565 is an FDA 510(k) clearance for the MODIFICATION TO NC-STAT. Classified as Device, Nerve Conduction Velocity Measurement (product code JXE), Class II - Special Controls.

Submitted by Neurometrix, Inc. (North Attleboro, US). The FDA issued a Cleared decision on June 27, 2000 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1550 - 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 Neurometrix, Inc. devices

Submission Details

510(k) Number K000565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2000
Decision Date June 27, 2000
Days to Decision 126 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
22d faster than avg
Panel avg: 148d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JXE Device, Nerve Conduction Velocity Measurement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1550
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.