Cleared Traditional

K953684 - GSI 61 CLINICAL AUDIOMETER

K953684 is an FDA 510(k) clearance for GSI 61 CLINICAL AUDIOMETER, manufactured by 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 85-day FDA review.

K953684 · Grason-Stadler, Inc. · Ear, Nose, Throat device
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Oct 1995
Decision
85d
Days
Class 2
Risk

K953684 is an FDA 510(k) clearance for the GSI 61 CLINICAL AUDIOMETER. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Grason-Stadler, Inc. (Milford, US). The FDA issued a Cleared decision on October 27, 1995 after a review of 85 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Grason-Stadler, Inc. devices

FDA 510(k) Submission Details - K953684

510(k) Number K953684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1995
Decision Date October 27, 1995
Days to Decision 85 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
4d faster than avg
Panel avg: 89d · This submission: 85d
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 63
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K953684.
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