Cleared Traditional

K944735 - BIO-LOGIC EMAV EMISSION AVERAGING OTOAC...

K944735 is an FDA 510(k) clearance for BIO-LOGIC EMAV EMISSION AVERAGING OTOAC..., manufactured by Bio-Logic Systems Corp.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K944735 · Bio-Logic Systems Corp. · Ear, Nose, Throat device
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Dec 1994
Decision
86d
Days
Class 2
Risk

K944735 is an FDA 510(k) clearance for the BIO-LOGIC EMAV EMISSION AVERAGING OTOACOUSTIC TEST. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Bio-Logic Systems Corp. (Mudelein, US). The FDA issued a Cleared decision on December 21, 1994 after a review of 86 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 Bio-Logic Systems Corp. devices

FDA 510(k) Submission Details - K944735

510(k) Number K944735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1994
Decision Date December 21, 1994
Days to Decision 86 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 89d · This submission: 86d
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 56
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K944735.
SCOUT SPORT - A MODIFICATION TO (FORMERLY EMAV) OTOACOUSTIC EMISSIONS (OAE) TEST INSTRUMENT
K961447 · Bio-Logic Systems Corp. · May 1996
PROPHET
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BELTONE PERSONAL HEARING SCREENER
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AUDIO EXPERT AUDIOMETER
K942716 · Beltone Electronics Corp. · Sep 1994
KS 5 - CLINICAL AUDIOMETER
K931322 · Maico Hearing Instruments, Inc. · Aug 1994
BELTONE SERIES 100 AUDIOMETERS
K940216 · Beltone Electronics Corp. · Jul 1994