Cleared Traditional

K960761 - PATHWAY ELECTROMYOGRAPH MODEL TR-10 & TR-20 (FDA 510(k) Clearance)

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

K960761 · The Prometheus Group · Neurology device
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Aug 1996
Decision
163d
Days
Class 2
Risk

K960761 is an FDA 510(k) clearance for the PATHWAY ELECTROMYOGRAPH MODEL TR-10 & TR-20. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by The Prometheus Group (Duxbury, US). The FDA issued a Cleared decision on August 7, 1996 after a review of 163 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5050 - 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 The Prometheus Group devices

Submission Details

510(k) Number K960761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1996
Decision Date August 07, 1996
Days to Decision 163 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
15d slower than avg
Panel avg: 148d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HCC Device, Biofeedback
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5050
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.