Cleared Traditional

LSVT C OR LSVT COMPANION, MODEL V.1 (K091682) - FDA 510(k) Clearance

K091682 · Lsvt Global, LLC · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Aug 2009
Decision
71d
Days
-
Risk

K091682 is an FDA 510(k) clearance for the LSVT C OR LSVT COMPANION, MODEL V.1. Classified as Aids, Speech Training For The Hearing Impaired (ac-powered And Patient-contact) (product code LEZ).

Submitted by Lsvt Global, LLC (Tucson, US). The FDA issued a Cleared decision on August 20, 2009 after a review of 71 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 K091682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2009
Decision Date August 20, 2009
Days to Decision 71 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
18d faster than avg
Panel avg: 89d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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