Cleared Abbreviated

K000097 - GSI 2000 MIDDLE EAR ANALYZER (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K000097 · Grason-Stadler, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
90d
Days
Class 2
Risk

K000097 is an FDA 510(k) clearance for the GSI 2000 MIDDLE EAR ANALYZER. Classified as Tester, Auditory Impedance (product code ETY), Class II - Special Controls.

Submitted by Grason-Stadler, Inc. (Milford, US). The FDA issued a Cleared decision on April 12, 2000 after a review of 90 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Grason-Stadler, Inc. devices

Submission Details

510(k) Number K000097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2000
Decision Date April 12, 2000
Days to Decision 90 days
Submission Type Abbreviated
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 89d · This submission: 90d
Pathway characteristics
Standards-based clearance path.

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.