Cleared Traditional

K934658 - GSI 60 DPOAE SYSTEM

K934658 is an FDA 510(k) clearance for GSI 60 DPOAE SYSTEM, manufactured by Lucas Grason-Stadler, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K934658 · Lucas Grason-Stadler, Inc. · Ear, Nose, Throat device
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Feb 1994
Decision
126d
Days
Class 2
Risk

K934658 is an FDA 510(k) clearance for the GSI 60 DPOAE SYSTEM. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Lucas Grason-Stadler, Inc. (Milford, US). The FDA issued a Cleared decision on February 1, 1994 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1050 - 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 - K934658

510(k) Number K934658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1993
Decision Date February 01, 1994
Days to Decision 126 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
37d slower than avg
Panel avg: 89d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EWO Device Classification - Class 2, Special Controls

Product Code EWO Audiometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1050
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 - EWO Audiometer

All 55
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K934658.
KS 5 - CLINICAL AUDIOMETER
K931322 · Maico Hearing Instruments, Inc. · Aug 1994
BELTONE SERIES 100 AUDIOMETERS
K940216 · Beltone Electronics Corp. · Jul 1994
ODYSSEY CLINICAL AUDIOMETER
K935348 · Qualitone · Feb 1994
MA25 - PORTABLE AUDIOMETER, MODIFICATION
K926439 · Maico Hearing Instruments, Inc. · Aug 1993
MAICO MA790 AUDIOMETER
K930112 · Maico Hearing Instruments, Inc. · Aug 1993
AT-2
K923007 · Qualitone · Feb 1993