Cleared Traditional

K033645 - OTOFLEX 100 TYE 1012

K033645 is an FDA 510(k) clearance for OTOFLEX 100 TYE 1012, manufactured by Gn Otometrics A/S. The device is a Class 2 Ear, Nose, Throat device with product code ETY cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K033645 · Gn Otometrics A/S · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
132d
Days
Class 2
Risk

K033645 is an FDA 510(k) clearance for the OTOFLEX 100 TYE 1012. Classified as Tester, Auditory Impedance (product code ETY), Class II - Special Controls.

Submitted by Gn Otometrics A/S (Taastrup, DK). The FDA issued a Cleared decision on March 31, 2004 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1090 - 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 Gn Otometrics A/S devices

FDA 510(k) Submission Details - K033645

510(k) Number K033645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2003
Decision Date March 31, 2004
Days to Decision 132 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
42d slower than avg
Panel avg: 90d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETY Device Classification - Class 2, Special Controls

Product Code ETY Tester, Auditory Impedance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1090
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 - ETY Tester, Auditory Impedance

All 46
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