Cleared Traditional

K925585 - GSI 38 AUTO TYMP

K925585 is an FDA 510(k) clearance for GSI 38 AUTO TYMP, manufactured by Lucas Grason-Stadler, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETY cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K925585 · Lucas Grason-Stadler, Inc. · Ear, Nose, Throat device
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Feb 1993
Decision
90d
Days
Class 2
Risk

K925585 is an FDA 510(k) clearance for the GSI 38 AUTO TYMP. Classified as Tester, Auditory Impedance (product code ETY), Class II - Special Controls.

Submitted by Lucas Grason-Stadler, Inc. (Littleton, US). The FDA issued a Cleared decision on February 2, 1993 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 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 Lucas Grason-Stadler, Inc. devices

FDA 510(k) Submission Details - K925585

510(k) Number K925585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1992
Decision Date February 02, 1993
Days to Decision 90 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
At panel average
Panel avg: 90d · This submission: 90d
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 50
Devices cleared under the same product code (ETY) and FDA review panel - the closest regulatory comparables to K925585.
AE-207D TYMPANOMETER
K930165 · Amrex Electronics, Inc. · Apr 1993
HANDTYMP
K923072 · Life-Tech Intl., Inc. · Mar 1993
AUTOMATIC TYMPANOMETER
K923073 · Life-Tech Intl., Inc. · Feb 1993
AE-206 TYMPNOMWRWE(R) AUDIOMETER
K924933 · American Electromedics Corp. · Jan 1993
AUTOMATIC IMPEDANCE METER AE-205
K924934 · American Electromedics Corp. · Jan 1993
ZODIAC 901 MIDDLE-EAR ANALYZER
K910247 · Madsen Electronics (Canada) , Ltd. · Jun 1991