Cleared Traditional

K962995 - ILO88. OTODYNAMIC ANALYSER

K962995 is an FDA 510(k) clearance for ILO88. OTODYNAMIC ANALYSER, manufactured by Otodynamics, Ltd.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K962995 · Otodynamics, Ltd. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Jan 1997
Decision
162d
Days
Class 2
Risk

K962995 is an FDA 510(k) clearance for the ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Otodynamics, Ltd. (Hatfield Herts Al10 8bb, GB). The FDA issued a Cleared decision on January 10, 1997 after a review of 162 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 Otodynamics, Ltd. devices

FDA 510(k) Submission Details - K962995

510(k) Number K962995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1996
Decision Date January 10, 1997
Days to Decision 162 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
73d slower than avg
Panel avg: 89d · This submission: 162d
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 56
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K962995.
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PROPHET
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