Cleared Traditional

K863353 - MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER) (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K863353 · Grason-Stadler, Inc. · Ear, Nose, Throat device
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Nov 1986
Decision
66d
Days
Class 2
Risk

K863353 is an FDA 510(k) clearance for the MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER). Classified as Tester, Auditory Impedance (product code ETY), Class II - Special Controls.

Submitted by Grason-Stadler, Inc. (Littleton, US). The FDA issued a Cleared decision on November 3, 1986 after a review of 66 days - a notably fast clearance cycle.

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: 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

Submission Details

510(k) Number K863353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1986
Decision Date November 03, 1986
Days to Decision 66 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 89d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.