Cleared Traditional

K770617 - AUDIOMETER

K770617 is the FDA 510(k) clearance for AUDIOMETER by Maico Hearing Instruments, Inc.. It is a Class 2 Ear, Nose, Throat device (product code EWO) cleared through the Traditional 510(k) pathway after a 6-day FDA review.

K770617 · Maico Hearing Instruments, Inc. · Ear, Nose, Throat device
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Apr 1977
Decision
6d
Days
Class 2
Risk

K770617 is an FDA 510(k) clearance for the AUDIOMETER, MA30, AIR & BONE CONDUCTION. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Maico Hearing Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 7, 1977 after a review of 6 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

Submission Details

510(k) Number K770617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1977
Decision Date April 07, 1977
Days to Decision 6 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
83d faster than avg
Panel avg: 89d · This submission: 6d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 54
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K770617.
COMPUTER AUDIOMETER - MA26
K780270 · Maico Hearing Instruments, Inc. · Feb 1978
AUDIOMETER, MA29, PURE TONE AIR CONDUCT.
K770616 · Maico Hearing Instruments, Inc. · Apr 1977
AUDIOMETER, MA31
K770618 · Maico Hearing Instruments, Inc. · Apr 1977
AUDIOMETER, DIAG., ADVANCED, MA-22
K770553 · Maico Hearing Instruments, Inc. · Mar 1977