Cleared Traditional

K863353 - MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER)

K863353 is an FDA 510(k) clearance for MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER), manufactured by 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 66-day FDA review.

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

FDA 510(k) Submission Details - K863353

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.

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 23
Devices cleared under the same product code (ETY) and FDA review panel - the closest regulatory comparables to K863353.
AE-105D DIAGNOSTIC TYMPANOMETER
K894260 · American Electromedics Corp. · Jan 1990
STORZ DX CENTER:IMPEDANCE TEST W/RHINO & AUDIO OPT
K883293 · Storz Instrument Co. · Jun 1989
AUTO IMPEDANCE METER AE105 & AE106 W/AUDIOMETER
K883728 · American Electromedics Corp. · Jan 1989
WELCH ALLYN TYMPANOMETER
K861516 · Welch Allyn, Inc. · Jun 1986
IMPEDANCE/PURE TONE AUDIOMETER MA620
K841568 · Maico Hearing Instruments, Inc. · Jul 1984
CLINICAL TYMPANOMETER
K833045 · American Electromedics Corp. · Dec 1983