Cleared Traditional

K883293 - STORZ DX CENTER:IMPEDANCE TEST W/RHINO & AUDIO OPT (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K883293 · Storz Instrument Co. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1989
Decision
309d
Days
Class 2
Risk

K883293 is an FDA 510(k) clearance for the STORZ DX CENTER:IMPEDANCE TEST W/RHINO & AUDIO OPT. Classified as Tester, Auditory Impedance (product code ETY), Class II - Special Controls.

Submitted by Storz Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on June 9, 1989 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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.

View all Storz Instrument Co. devices

Submission Details

510(k) Number K883293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1988
Decision Date June 09, 1989
Days to Decision 309 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
220d slower than avg
Panel avg: 89d · This submission: 309d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.