Cleared Traditional

K902068 - HEARING AMBASSADOR-HEAR PEN SCREENING A...

K902068 is the FDA 510(k) clearance for HEARING AMBASSADOR-HEAR PEN SCREENING A... by Starkey Laboratories, Inc.. It is a Class 2 Ear, Nose, Throat device (product code EWO) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K902068 · Starkey Laboratories, Inc. · Ear, Nose, Throat device
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Aug 1990
Decision
91d
Days
Class 2
Risk

K902068 is an FDA 510(k) clearance for the HEARING AMBASSADOR-HEAR PEN SCREENING AUDIOMETER. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Starkey Laboratories, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on August 6, 1990 after a review of 91 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 Starkey Laboratories, Inc. devices

Submission Details

510(k) Number K902068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1990
Decision Date August 06, 1990
Days to Decision 91 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
2d slower than avg
Panel avg: 89d · This submission: 91d
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 31
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K902068.
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K890842 · Maico Hearing Instruments, Inc. · Jun 1989