Cleared Traditional

K945689 - GAME AUDIOMETERY WORD IDENTIFICATION AU...

K945689 is an FDA 510(k) clearance for GAME AUDIOMETERY WORD IDENTIFICATION AU..., manufactured by Calmed Technology, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K945689 · Calmed Technology, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
79d
Days
Class 2
Risk

K945689 is an FDA 510(k) clearance for the GAME AUDIOMETERY WORD IDENTIFICATION AUDIOMETRY FOR USE WITH PRODIGIT(TM) 200.... Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Calmed Technology, Inc. (Union City, US). The FDA issued a Cleared decision on February 8, 1995 after a review of 79 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 Calmed Technology, Inc. devices

FDA 510(k) Submission Details - K945689

510(k) Number K945689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1994
Decision Date February 08, 1995
Days to Decision 79 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 89d · This submission: 79d
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 K945689.
SCOUT SPORT - A MODIFICATION TO (FORMERLY EMAV) OTOACOUSTIC EMISSIONS (OAE) TEST INSTRUMENT
K961447 · Bio-Logic Systems Corp. · May 1996
PROPHET
K953884 · Qualitone · Oct 1995
BELTONE PERSONAL HEARING SCREENER
K943616 · Beltone Electronics Corp. · Jul 1995
BIO-LOGIC EMAV EMISSION AVERAGING OTOACOUSTIC TEST
K944735 · Bio-Logic Systems Corp. · Dec 1994
AUDIO EXPERT AUDIOMETER
K942716 · Beltone Electronics Corp. · Sep 1994
KS 5 - CLINICAL AUDIOMETER
K931322 · Maico Hearing Instruments, Inc. · Aug 1994