Cleared Traditional

K926574 - MODEL 330 SCREENING AUDIO METER

K926574 is the FDA 510(k) clearance for MODEL 330 SCREENING AUDIO METER by Virtual Corp.. It is a Class 2 Neurology device (product code GWJ) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K926574 · Virtual Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1993
Decision
89d
Days
Class 2
Risk

K926574 is an FDA 510(k) clearance for the MODEL 330 SCREENING AUDIO METER, MODIFIED. Classified as Stimulator, Auditory, Evoked Response (product code GWJ), Class II - Special Controls.

Submitted by Virtual Corp. (Portland, US). The FDA issued a Cleared decision on March 29, 1993 after a review of 89 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. 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 Virtual Corp. devices

Submission Details

510(k) Number K926574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1992
Decision Date March 29, 1993
Days to Decision 89 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
59d faster than avg
Panel avg: 148d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 17
Devices cleared under the same product code (GWJ) and FDA review panel - the closest regulatory comparables to K926574.
MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO.
K994149 · Bio-Logic Systems Corp. · Dec 1999
BIO-LOGIC EVOKED POTENTIAL FOR ABAER I
K992807 · Bio-Logic Systems Corp. · Sep 1999
EXCEL AV STIM 1000
K972157 · Excel Tech. , Ltd. · Jan 1998
EVOPORT 100
K863985 · Jedmed Instrument Co. · Jan 1987
40-HZ AUDITORY EVOKED RESPONSE TEST
K862361 · Cadwell Laboratories, Inc. · Sep 1986
INSERT EARPHONES
K862363 · Cadwell Laboratories, Inc. · Sep 1986