Cleared Traditional

K003913 - HINT AUDIOMETER

K003913 is an FDA 510(k) clearance for HINT AUDIOMETER, manufactured by Maico-Diagnostics. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K003913 · Maico-Diagnostics · Ear, Nose, Throat device
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Mar 2001
Decision
87d
Days
Class 2
Risk

K003913 is an FDA 510(k) clearance for the HINT AUDIOMETER, OR HINT. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Maico-Diagnostics (Eden Prairie, US). The FDA issued a Cleared decision on March 16, 2001 after a review of 87 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 Maico-Diagnostics devices

FDA 510(k) Submission Details - K003913

510(k) Number K003913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2000
Decision Date March 16, 2001
Days to Decision 87 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 89d · This submission: 87d
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 K003913.
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