Cleared Abbreviated

K000097 - GSI 2000 MIDDLE EAR ANALYZER

K000097 is an FDA 510(k) clearance for GSI 2000 MIDDLE EAR ANALYZER, manufactured by Grason-Stadler, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETY cleared through the Abbreviated 510(k) pathway after a 90-day FDA review.

K000097 · Grason-Stadler, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K000097

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 90d · This submission: 90d
Pathway characteristics
Standards-based clearance path.

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 52
Devices cleared under the same product code (ETY) and FDA review panel - the closest regulatory comparables to K000097.
OTOFLEX 100 TYE 1012
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AMPLAID A756 SCREENING ADMITTANCE METER
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AUDIOTRAVELLER, MODEL AA222
K022728 · Interacoustics A/S, Assens · Oct 2002
INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER
K994254 · International Distributors of Electronics For Medi · Mar 2000
PASCAL MEDICAL AB MENIETT 20
K991562 · Pascal Medical AB · Dec 1999
AMPLAID A724 AND A728
K992370 · Amplifon S.P.A. · Sep 1999