Cleared Traditional

K912436 - AM-PAK

K912436 is an FDA 510(k) clearance for AM-PAK, manufactured by Cns, Inc.. The device is a Class 2 Neurology device with product code GWL cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K912436 · Cns, Inc. · Neurology device
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Oct 1991
Decision
137d
Days
Class 2
Risk

K912436 is an FDA 510(k) clearance for the AM-PAK. Classified as Amplifier, Physiological Signal (product code GWL), Class II - Special Controls.

Submitted by Cns, Inc. (Chanhassen, US). The FDA issued a Cleared decision on October 18, 1991 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1835 - 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 Cns, Inc. devices

FDA 510(k) Submission Details - K912436

510(k) Number K912436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1991
Decision Date October 18, 1991
Days to Decision 137 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
11d faster than avg
Panel avg: 148d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWL Device Classification - Class 2, Special Controls

Product Code GWL Amplifier, Physiological Signal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1835
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.

Regulatory Peers - GWL Amplifier, Physiological Signal

All 35
Devices cleared under the same product code (GWL) and FDA review panel - the closest regulatory comparables to K912436.
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