Cleared Traditional

K973320 - ARTICULATE FITTING SYSTEM

K973320 is an FDA 510(k) clearance for ARTICULATE FITTING SYSTEM, manufactured by Decibel 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 83-day FDA review.

K973320 · Decibel Instruments, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
83d
Days
Class 2
Risk

K973320 is an FDA 510(k) clearance for the ARTICULATE FITTING SYSTEM. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Decibel Instruments, Inc. (Houston, US). The FDA issued a Cleared decision on November 25, 1997 after a review of 83 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 Decibel Instruments, Inc. devices

FDA 510(k) Submission Details - K973320

510(k) Number K973320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1997
Decision Date November 25, 1997
Days to Decision 83 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
7d faster than avg
Panel avg: 90d · This submission: 83d
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 K973320.
SIBELMED AC50D
K973377 · Trutone · Mar 1998
GSI 70 AUDIOPATH SCREENER
K974237 · Grason-Stadler, Inc. · Feb 1998
SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE
K974076 · Bio-Logic Systems Corp. · Jan 1998
AMPLAID 171S
K972862 · Amplifon S.P.A. · Oct 1997
K 15 AUDIOMETER
K972221 · American Electromedics Corp. · Sep 1997
AMPLAID 460
K971747 · Amplifon S.P.A. · Aug 1997