Cleared Traditional

VISIVOX, MODEL V-2 (K982396) - FDA 510(k) Clearance

K982396 · Rsq, LLC · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
67d
Days
-
Risk

K982396 is an FDA 510(k) clearance for the VISIVOX, MODEL V-2. Classified as Aids, Speech Training For The Hearing Impaired (ac-powered And Patient-contact) (product code LEZ).

Submitted by Rsq, LLC (Claremont, US). The FDA issued a Cleared decision on September 14, 1998 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel. 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.

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Submission Details

510(k) Number K982396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1998
Decision Date September 14, 1998
Days to Decision 67 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 89d · This submission: 67d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LEZ Aids, Speech Training For The Hearing Impaired (ac-powered And Patient-contact)
Device Class -