Cleared Abbreviated

K093006 - FONIX ,MODEL 8000 (FDA 510(k) Clearance)

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

K093006 · Frye Electronics, Inc. · Ear, Nose, Throat device
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Dec 2009
Decision
93d
Days
Class 2
Risk

K093006 is an FDA 510(k) clearance for the FONIX ,MODEL 8000. Classified as Calibrator, Hearing Aid / Earphone And Analysis Systems (product code ETW), Class II - Special Controls.

Submitted by Frye Electronics, Inc. (Tigard, US). The FDA issued a Cleared decision on December 30, 2009 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3310 - 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 Frye Electronics, Inc. devices

Submission Details

510(k) Number K093006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2009
Decision Date December 30, 2009
Days to Decision 93 days
Submission Type Abbreviated
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 89d · This submission: 93d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code ETW Calibrator, Hearing Aid / Earphone And Analysis Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3310
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.