Cleared Traditional

K945689 - GAME AUDIOMETERY WORD IDENTIFICATION AUDIOMETRY FOR USE WITH PRODIGIT(TM) 2000 PERSONAL DIGITAL AUDIOMETER(TM)

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
11d faster than avg
Panel avg: 90d · 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 147
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K945689.
BELTONE PERSONAL HEARING SCREENER
K943616 · Beltone Electronics Corp. · Jul 1995
GSI 65 COMPUTERIZED AUDIOMETER
K951759 · Grason-Stadler, Inc. · Jul 1995
THE PILOT AUDIOMETER
K951527 · American Electromedics Corp. · May 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