Cleared Traditional

K895785 - AUDIOMETER MODEL MD-4, MD-4P

K895785 is an FDA 510(k) clearance for AUDIOMETER MODEL MD-4, 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 132-day FDA review.

K895785 · Singer Medical Products, Inc. · Ear, Nose, Throat device
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Dec 1989
Decision
132d
Days
Class 2
Risk

K895785 is an FDA 510(k) clearance for the AUDIOMETER MODEL MD-4, MD-4P. 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 December 5, 1989 after a review of 132 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.

FDA 510(k) Submission Details - K895785

510(k) Number K895785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1989
Decision Date December 05, 1989
Days to Decision 132 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 90d · This submission: 132d
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 176
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K895785.
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
IMPEDANCE ANALYZER/AUDIOMETER MODEL MD-3
K895784 · Singer Medical Products, Inc. · Dec 1989
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
K895785 · AUDIOMETER MODEL MD-4, MD-4P
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