Cleared Traditional

K930553 - CUB DIS OTOACOUSTIC EMISSIONS TEST INST...

K930553 is the FDA 510(k) clearance for CUB DIS OTOACOUSTIC EMISSIONS TEST INST... by Etymotic Research. It is a Class 2 Ear, Nose, Throat device (product code EWO) cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K930553 · Etymotic Research · Ear, Nose, Throat device
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Sep 1993
Decision
238d
Days
Class 2
Risk

K930553 is an FDA 510(k) clearance for the CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Etymotic Research (Elk Grove Village, US). The FDA issued a Cleared decision on September 29, 1993 after a review of 238 days - an extended review 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: 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 Etymotic Research devices

Submission Details

510(k) Number K930553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1993
Decision Date September 29, 1993
Days to Decision 238 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
149d slower than avg
Panel avg: 89d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K930553.
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