Cleared Traditional

K071973 - EPLEY OMNIAX

K071973 · Vesticon · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
339d
Days
-
Risk

K071973 is an FDA 510(k) clearance for the EPLEY OMNIAX. Classified as Apparatus, Vestibular Analysis (product code LXV).

Submitted by Vesticon (Portland, US). The FDA issued a Cleared decision on June 20, 2008 after a review of 339 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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.

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FDA 510(k) Submission Details - K071973

510(k) Number K071973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2007
Decision Date June 20, 2008
Days to Decision 339 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
250d slower than avg
Panel avg: 89d · This submission: 339d
Pathway characteristics
Predicate-based equivalence.

LXV Device Classification - Class 0,

Product Code LXV Apparatus, Vestibular Analysis
Device Class -