Cleared Traditional

K950986 - NEUROREADER

K950986 is an FDA 510(k) clearance for NEUROREADER, manufactured by Artronics. The device is a Class 2 Neurology device with product code HCS cleared through the Traditional 510(k) pathway after a 251-day FDA review.

K950986 · Artronics · Neurology device
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Nov 1995
Decision
251d
Days
Class 2
Risk

K950986 is an FDA 510(k) clearance for the NEUROREADER. Classified as Device, Temperature Measurement, Direct Contact, Powered (product code HCS), Class II - Special Controls.

Submitted by Artronics (Easley, US). The FDA issued a Cleared decision on November 9, 1995 after a review of 251 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1570 - 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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FDA 510(k) Submission Details - K950986

510(k) Number K950986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1995
Decision Date November 09, 1995
Days to Decision 251 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
103d slower than avg
Panel avg: 148d · This submission: 251d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCS Device Classification - Class 2, Special Controls

Product Code HCS Device, Temperature Measurement, Direct Contact, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1570
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.