Cleared Traditional

K043396 - INTEGRITY, MODEL V500

K043396 is an FDA 510(k) clearance for INTEGRITY, manufactured by Vivosonic, Inc.. The device is a Class 2 Neurology device with product code GWJ cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K043396 · Vivosonic, Inc. · Neurology device
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Jan 2005
Decision
45d
Days
Class 2
Risk

K043396 is an FDA 510(k) clearance for the INTEGRITY, MODEL V500. Classified as Stimulator, Auditory, Evoked Response (product code GWJ), Class II - Special Controls.

Submitted by Vivosonic, Inc. (Toronto, On, CA). The FDA issued a Cleared decision on January 24, 2005 after a review of 45 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 Vivosonic, Inc. devices

FDA 510(k) Submission Details - K043396

510(k) Number K043396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2004
Decision Date January 24, 2005
Days to Decision 45 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 149d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Entela, Inc.
N.E. DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GWJ Stimulator, Auditory, Evoked Response

All 54
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