Cleared Traditional

K862770 - AUDIOMETER/MASTER HEARING AID MF6

K862770 is an FDA 510(k) clearance for AUDIOMETER/MASTER HEARING AID MF6, 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 24-day FDA review.

K862770 · Maico Hearing Instruments, Inc. · Ear, Nose, Throat device
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Aug 1986
Decision
24d
Days
Class 2
Risk

K862770 is an FDA 510(k) clearance for the AUDIOMETER/MASTER HEARING AID MF6. 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 15, 1986 after a review of 24 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 Hearing Instruments, Inc. devices

FDA 510(k) Submission Details - K862770

510(k) Number K862770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1986
Decision Date August 15, 1986
Days to Decision 24 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 90d · This submission: 24d
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 K862770.
AE1162 CLINICAL/DIAGNOSTIC AUDIOMETER
K881760 · American Electromedics Corp. · Jun 1988
THE BELTONE 2000 AUDIOMETER
K875360 · Beltone Electronics Corp. · Feb 1988
PHOENIX SYSTEM SEVEN.
K862592 · Nicolet Biomedical Instruments · Sep 1986
DAHLBERG MODEL GF MICROPROCESSOR AUDIOMETER
K854835 · Miracle-Ear/Dahlberg, Inc. · Mar 1986
DIGITAL SCREENING AUDIOMETER DSA6214
K854534 · Madsen Electronics (Canada) , Ltd. · Feb 1986
MA25 PORTABLE AUDIOMETER
K853919 · Maico Hearing Instruments, Inc. · Dec 1985