Cleared Traditional

K890497 - MODEL 20-P EXTENDED HIGH FREQUENCY AUDI...

K890497 is an FDA 510(k) clearance for MODEL 20-P EXTENDED HIGH FREQUENCY AUDI..., manufactured by Monitor/Demlar. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K890497 · Monitor/Demlar · Ear, Nose, Throat device
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Jun 1989
Decision
125d
Days
Class 2
Risk

K890497 is an FDA 510(k) clearance for the MODEL 20-P EXTENDED HIGH FREQUENCY AUDIOMETER. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Monitor/Demlar (Hillsborough, US). The FDA issued a Cleared decision on June 6, 1989 after a review of 125 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Monitor/Demlar devices

FDA 510(k) Submission Details - K890497

510(k) Number K890497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1989
Decision Date June 06, 1989
Days to Decision 125 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
36d slower than avg
Panel avg: 89d · This submission: 125d
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 K890497.
AUDIOMETER/MASTER HEARING AID, MAICO MODEL MF7
K895310 · Maico Hearing Instruments, Inc. · Jan 1990
AUDIOMETER AI1, ME1 AND SA1 & MASTER HEARING AID
K890993 · Maico Hearing Instruments, Inc. · Oct 1989
2400 AUDIOMETER, IMPEDANCE METER & HRNG. AID ANALY
K890842 · Maico Hearing Instruments, Inc. · Jun 1989
AUDIOSCOPE 3 MODEL 23300 ACCESSORIES
K884218 · Welch Allyn, Inc. · Mar 1989
AUDIOMETER DIGITAL HEARING SYSTEM
K884044 · Resound Corp. · Feb 1989
THE BELTONE 2000 AUDIOMETER
K875360 · Beltone Electronics Corp. · Feb 1988