Cleared Traditional

K930112 - MAICO MA790 AUDIOMETER

K930112 is an FDA 510(k) clearance for MAICO MA790 AUDIOMETER, manufactured by Maico Hearing Instruments, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K930112 · Maico Hearing Instruments, Inc. · Ear, Nose, Throat device
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Aug 1993
Decision
206d
Days
Class 2
Risk

K930112 is an FDA 510(k) clearance for the MAICO MA790 AUDIOMETER. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Maico Hearing Instruments, Inc. (Minneapolis, US). The FDA issued a Cleared decision on August 5, 1993 after a review of 206 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 Maico Hearing Instruments, Inc. devices

FDA 510(k) Submission Details - K930112

510(k) Number K930112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1993
Decision Date August 05, 1993
Days to Decision 206 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
116d slower than avg
Panel avg: 90d · This submission: 206d
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 134
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K930112.
ORBITER 922 CLINICAL AUDIOMETER
K931324 · Madsen Electronics (Canada) , Ltd. · Nov 1993
AUDIOMETER DA 323
K933222 · Futuremed Div. of Future Impex Corp. · Nov 1993
MA25 - PORTABLE AUDIOMETER, MODIFICATION
K926439 · Maico Hearing Instruments, Inc. · Aug 1993
AT-2
K923007 · Qualitone · Feb 1993
ST 20 PORTABLE AUDIOMETER
K922746 · Maico Hearing Instruments, Inc. · Nov 1992
DANPLEX SCREENING AUDIOMETER
K923074 · Life-Tech Intl., Inc. · Sep 1992