Cleared Traditional

K974076 - SPORT/AUDX OAE TEST INSTRUMENT WITH BIO...

K974076 is an FDA 510(k) clearance for SPORT/AUDX OAE TEST INSTRUMENT WITH BIO..., 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 85-day FDA review.

K974076 · Bio-Logic Systems Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
85d
Days
Class 2
Risk

K974076 is an FDA 510(k) clearance for the SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE. 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 January 22, 1998 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 Bio-Logic Systems Corp. devices

FDA 510(k) Submission Details - K974076

510(k) Number K974076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1997
Decision Date January 22, 1998
Days to Decision 85 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
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 55
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K974076.
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