Cleared Traditional

K092089 - CLARUJUST

K092089 is an FDA 510(k) clearance for CLARUJUST, manufactured by Audigence, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K092089 · Audigence, Inc. · Ear, Nose, Throat device
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Mar 2010
Decision
244d
Days
Class 2
Risk

K092089 is an FDA 510(k) clearance for the CLARUJUST. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Audigence, Inc. (Melbourne, US). The FDA issued a Cleared decision on March 10, 2010 after a review of 244 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1050 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Audigence, Inc. devices

FDA 510(k) Submission Details - K092089

510(k) Number K092089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2009
Decision Date March 10, 2010
Days to Decision 244 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
155d slower than avg
Panel avg: 89d · This submission: 244d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EWO Device Classification - Class 2, Special Controls

Product Code EWO Audiometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1050
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 - EWO Audiometer

All 55
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K092089.
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