Cleared Traditional

K890842 - 2400 AUDIOMETER

K890842 is the FDA 510(k) clearance for 2400 AUDIOMETER by Maico Hearing Instruments, Inc.. It is a Class 2 Ear, Nose, Throat device (product code EWO) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K890842 · Maico Hearing Instruments, Inc. · Ear, Nose, Throat device
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Jun 1989
Decision
106d
Days
Class 2
Risk

K890842 is an FDA 510(k) clearance for the 2400 AUDIOMETER, IMPEDANCE METER & HRNG. AID ANALY. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Maico Hearing Instruments, Inc. (Minneapolis, US). The FDA issued a Cleared decision on June 7, 1989 after a review of 106 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 Maico Hearing Instruments, Inc. devices

Submission Details

510(k) Number K890842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1989
Decision Date June 07, 1989
Days to Decision 106 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
17d slower than avg
Panel avg: 89d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 54
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K890842.
HEARING AMBASSADOR-HEAR PEN SCREENING AUDIOMETER
K902068 · Starkey Laboratories, Inc. · Aug 1990
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
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