Cleared Traditional

K923013 - ACOUSTIC APPRAISE CD-3

K923013 is the FDA 510(k) clearance for ACOUSTIC APPRAISE CD-3 by Qualitone. It is a Class 2 Ear, Nose, Throat device (product code EWO) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K923013 · Qualitone · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1992
Decision
53d
Days
Class 2
Risk

K923013 is an FDA 510(k) clearance for the ACOUSTIC APPRAISE CD-3. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Qualitone (Minneapolis, US). The FDA issued a Cleared decision on August 14, 1992 after a review of 53 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 Qualitone devices

Submission Details

510(k) Number K923013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1992
Decision Date August 14, 1992
Days to Decision 53 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 89d · This submission: 53d
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 K923013.
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
THE BELTONE AUDIO SCOUT
K915323 · Beltone Electronics Corp. · May 1992
RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM
K912669 · Resound Corp. · Sep 1991
MAICO MA800 AUDIOMETER
K911368 · Maico Hearing Instruments, Inc. · Jun 1991