Cleared Abbreviated

K121793 - AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON (FDA 510(k) Clearance)

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

K121793 · Audifon-USA, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2012
Decision
135d
Days
Class 2
Risk

K121793 is an FDA 510(k) clearance for the AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON. Classified as Hearing Aid, Bone Conduction (product code LXB), Class II - Special Controls.

Submitted by Audifon-USA, Inc. (Debary, US). The FDA issued a Cleared decision on November 1, 2012 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3302 - 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 Audifon-USA, Inc. devices

Submission Details

510(k) Number K121793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2012
Decision Date November 01, 2012
Days to Decision 135 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
46d slower than avg
Panel avg: 89d · This submission: 135d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code LXB Hearing Aid, Bone Conduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3302
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.

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