Cleared Traditional

K974235 - AMPLAID AM50

K974235 is an FDA 510(k) clearance for AMPLAID AM50, manufactured by Amplifon S.P.A.. The device is a Class 2 Ear, Nose, Throat device with product code ETY cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K974235 · Amplifon S.P.A. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
90d
Days
Class 2
Risk

K974235 is an FDA 510(k) clearance for the AMPLAID AM50. Classified as Tester, Auditory Impedance (product code ETY), Class II - Special Controls.

Submitted by Amplifon S.P.A. (Deer Field, US). The FDA issued a Cleared decision on February 10, 1998 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 874.1090 - 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 Amplifon S.P.A. devices

FDA 510(k) Submission Details - K974235

510(k) Number K974235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1997
Decision Date February 10, 1998
Days to Decision 90 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
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. No clinical trials required.

ETY Device Classification - Class 2, Special Controls

Product Code ETY Tester, Auditory Impedance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1090
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 - ETY Tester, Auditory Impedance

All 11
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