Cleared Abbreviated

EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE (K093715) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K093715 · Magnatone Hearing Aid Corp. Dba Persona Medical · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
386d
Days
Class 2
Risk

K093715 is an FDA 510(k) clearance for the EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE. Classified as Masker, Tinnitus (product code KLW), Class II - Special Controls.

Submitted by Magnatone Hearing Aid Corp. Dba Persona Medical (Casselberry, US). The FDA issued a Cleared decision on December 22, 2010 after a review of 386 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3400 - the FDA ear, nose and throat device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Magnatone Hearing Aid Corp. Dba Persona Medical devices

Submission Details

510(k) Number K093715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2009
Decision Date December 22, 2010
Days to Decision 386 days
Submission Type Abbreviated
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
297d slower than avg
Panel avg: 89d · This submission: 386d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code KLW Masker, Tinnitus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3400
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - KLW Masker, Tinnitus

All 75
Devices cleared under the same product code (KLW) and FDA review panel - the closest regulatory comparables to K093715.
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