Cleared Traditional

K896909 - MD5 AUTOMATIC AUDIOMETER

K896909 is an FDA 510(k) clearance for MD5 AUTOMATIC AUDIOMETER, manufactured by Singer Medical Products, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K896909 · Singer Medical Products, Inc. · Ear, Nose, Throat device
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Mar 1990
Decision
84d
Days
Class 2
Risk

K896909 is an FDA 510(k) clearance for the MD5 AUTOMATIC AUDIOMETER. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Singer Medical Products, Inc. (Bensenville, US). The FDA issued a Cleared decision on March 5, 1990 after a review of 84 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.

FDA 510(k) Submission Details - K896909

510(k) Number K896909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1989
Decision Date March 05, 1990
Days to Decision 84 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
6d faster than avg
Panel avg: 90d · This submission: 84d
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 178
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K896909.
HEARING AMBASSADOR-HEAR PEN SCREENING AUDIOMETER
K902068 · Starkey Laboratories, Inc. · Aug 1990
AUDIOTESTER SCREENING AUDIOMETER
K894484 · Prometex, Inc. · Jun 1990
MICROMATE 304
K896401 · Madsen North America, Inc. · Mar 1990
AUDIOMETER/MASTER HEARING AID, MAICO MODEL MF7
K895310 · Maico Hearing Instruments, Inc. · Jan 1990
MODEL EB-22 NOISE STIK
K895200 · Eckstein Brothers, Inc. · Jan 1990
IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1P
K894748 · Singer Medical Products, Inc. · Dec 1989
K896909 · MD5 AUTOMATIC AUDIOMETER
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