Cleared Traditional

K901503 - ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER...

K901503 is an FDA 510(k) clearance for ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER..., manufactured by Stanton Magnetics, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESE cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K901503 · Stanton Magnetics, Inc. · Ear, Nose, Throat device
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Jun 1990
Decision
90d
Days
Class 1
Risk

K901503 is an FDA 510(k) clearance for the ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEM. Classified as Larynx, Artificial (battery-powered) (product code ESE), Class I - General Controls.

Submitted by Stanton Magnetics, Inc. (Plainview, US). The FDA issued a Cleared decision on June 28, 1990 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3375 - 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 Stanton Magnetics, Inc. devices

FDA 510(k) Submission Details - K901503

510(k) Number K901503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1990
Decision Date June 28, 1990
Days to Decision 90 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
1d slower than avg
Panel avg: 89d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

ESE Device Classification - Class 1, General Controls

Product Code ESE Larynx, Artificial (battery-powered)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.3375
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.