Cleared Traditional

K841167 - DEMLAR SYS I COMPUTER BASED AUDIOMETER

K841167 is an FDA 510(k) clearance for DEMLAR SYS I COMPUTER BASED AUDIOMETER, manufactured by Demlar Medical, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K841167 · Demlar Medical, Inc. · Ear, Nose, Throat device
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Jun 1984
Decision
100d
Days
Class 2
Risk

K841167 is an FDA 510(k) clearance for the DEMLAR SYS I COMPUTER BASED AUDIOMETER. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Demlar Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 27, 1984 after a review of 100 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 Demlar Medical, Inc. devices

FDA 510(k) Submission Details - K841167

510(k) Number K841167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1984
Decision Date June 27, 1984
Days to Decision 100 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
11d slower than avg
Panel avg: 89d · This submission: 100d
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 K841167.
THE BELTONE 2000 AUDIOMETER
K875360 · Beltone Electronics Corp. · Feb 1988
AUDIOMETER/MASTER HEARING AID MF6
K862770 · Maico Hearing Instruments, Inc. · Aug 1986
MA25 PORTABLE AUDIOMETER
K853919 · Maico Hearing Instruments, Inc. · Dec 1985
AUDIOMETER MA728
K841567 · Maico Hearing Instruments, Inc. · Jun 1984
PORTABLE AUDIOMETERS
K811727 · Maico Hearing Instruments, Inc. · Jul 1981
TINNITUS RESEARCH AUDIOMETER
K802560 · Starkey Laboratories, Inc. · Nov 1980