Cleared Traditional

K770823 - AUDIOMETRIC TESTING SYS.

K770823 is an FDA 510(k) clearance for AUDIOMETRIC TESTING SYS., manufactured by Automated Testing Services, Ltd.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K770823 · Automated Testing Services, Ltd. · Ear, Nose, Throat device
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May 1977
Decision
14d
Days
Class 2
Risk

K770823 is an FDA 510(k) clearance for the AUDIOMETRIC TESTING SYS., SERIES 500. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Automated Testing Services, Ltd. (Mchenry, US). The FDA issued a Cleared decision on May 18, 1977 after a review of 14 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 Automated Testing Services, Ltd. devices

FDA 510(k) Submission Details - K770823

510(k) Number K770823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1977
Decision Date May 18, 1977
Days to Decision 14 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 89d · This submission: 14d
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 K770823.
AUDIOMETER, PORTABLE, AIR CONDUCTION
K780382 · Maico Hearing Instruments, Inc. · Mar 1978
COMPUTER AUDIOMETER - MA25
K780269 · Maico Hearing Instruments, Inc. · Feb 1978
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, MA30, AIR & BONE CONDUCTION
K770617 · Maico Hearing Instruments, Inc. · Apr 1977