Cleared Special

K052060 - OPTI-AMP DC-POWERED

K052060 is an FDA 510(k) clearance for OPTI-AMP DC-POWERED, manufactured by Intelligent Hearing Systems. The device is a Class 2 Neurology device with product code GWL cleared through the Special 510(k) pathway after a 33-day FDA review.

K052060 · Intelligent Hearing Systems · Neurology device

Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)

Optimized for regulatory review, auditing and printing

Aug 2005

Decision

33d

Days

Class 2

Risk

K052060 is an FDA 510(k) clearance for the OPTI-AMP DC-POWERED. Classified as Amplifier, Physiological Signal (product code GWL), Class II - Special Controls.

Submitted by Intelligent Hearing Systems (Miami, US). The FDA issued a Cleared decision on August 31, 2005 after a review of 33 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K052060

510(k) Number	K052060 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 29, 2005
Decision Date	August 31, 2005
Days to Decision	33 days
Submission Type	Special
Review Panel	Neurology (NE)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

116d faster than avg

Panel avg: 149d · This submission: 33d

Pathway characteristics

Modification to existing cleared device.

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 46

Devices cleared under the same product code (GWL) and FDA review panel - the closest regulatory comparables to K052060.

G.USBAMP

K060803 · G.Tec Medical Engineering GmbH · May 2006

BE PLUS / AURA-LTM64 AMPLIFIER

K053606 · Eb Neuro S.P.A. · Jan 2006

SINGLE AMPLIFIER FOR BOTOX

K051852 · Allergan, Inc. · Sep 2005

NIC36 AMPLIFIER

K041198 · Eb Neuro S.P.A. · Jun 2004

SANDMAN SD20 AMPLIFIER

K040113 · Eb Neuro S.P.A. · Feb 2004

MIZAR, BASIS BE, SANDMAN DIGITAL

K003154 · Eb Neuro S.P.A. · Jan 2001

FDA 510(k) Resources - Neurology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K052060

Intelligent Hearing Systems

Miami, FL · US

EDWARD MISKIEL

Regulatory profile

13 submissions 13 cleared

100% clearance rate · Active in Neurology

View all devices by Intelligent Hearing Systems →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: August 31, 2005. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: September 2026.

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