Cleared Traditional

K914876 - OPTI-AMP

K914876 is the FDA 510(k) clearance for OPTI-AMP by Intelligent Hearing Systems. It is a Class 2 Neurology device (product code GWL) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K914876 · Intelligent Hearing Systems · Neurology device
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Jan 1992
Decision
73d
Days
Class 2
Risk

K914876 is an FDA 510(k) clearance for the OPTI-AMP. Classified as Amplifier, Physiological Signal (product code GWL), Class II - Special Controls.

Submitted by Intelligent Hearing Systems (North Miami, US). The FDA issued a Cleared decision on January 10, 1992 after a review of 73 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Intelligent Hearing Systems devices

Submission Details

510(k) Number K914876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1991
Decision Date January 10, 1992
Days to Decision 73 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
75d faster than avg
Panel avg: 148d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 17
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K841612 · Nihon Kohden America, Inc. · Jun 1984