Cleared Special

K061443 - SMART USBLITE, MODEL M011120

K061443 is an FDA 510(k) clearance for SMART USBLITE, manufactured by Intelligent Hearing Systems. The device is a Class 2 Neurology device with product code GWJ cleared through the Special 510(k) pathway after a 30-day FDA review.

K061443 · Intelligent Hearing Systems · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
30d
Days
Class 2
Risk

K061443 is an FDA 510(k) clearance for the SMART USBLITE, MODEL M011120. Classified as Stimulator, Auditory, Evoked Response (product code GWJ), Class II - Special Controls.

Submitted by Intelligent Hearing Systems (Miami, US). The FDA issued a Cleared decision on June 23, 2006 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1900 - 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 - K061443

510(k) Number K061443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2006
Decision Date June 23, 2006
Days to Decision 30 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
119d faster than avg
Panel avg: 149d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

GWJ Device Classification - Class 2, Special Controls

Product Code GWJ Stimulator, Auditory, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1900
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 - GWJ Stimulator, Auditory, Evoked Response

All 66
Devices cleared under the same product code (GWJ) and FDA review panel - the closest regulatory comparables to K061443.
ALGO 5 NEWBORN HEARING SCREENER
K073665 · Natus Medical, Inc. · Jan 2008
SMARTEP, MODEL M010000
K070608 · Intelligent Hearing Systems · Jul 2007
INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME)
K070696 · Interacoustics A/S · Jun 2007
INTEGRITY, MODEL V500
K043396 · Vivosonic, Inc. · Jan 2005
SMARTEP-ASSR, MODEL M811007
K031051 · Intelligent Hearing Systems · Feb 2004
STACKED ABR FOR NAVIGATOR PRO
K030907 · Bio-Logic Systems Corp. · May 2003
K061443 · SMART USBLITE, MODEL M011120
Download PDF FDA Summary Intelligent Hearing S…