Cleared Traditional

AMPLAID A724 AND A728 (K992370) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K992370 · Amplifon S.P.A. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
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Sep 1999
Decision
67d
Days
Class 2
Risk

K992370 is an FDA 510(k) clearance for the AMPLAID A724 AND A728. 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 September 20, 1999 after a review of 67 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Amplifon S.P.A. devices

Submission Details

510(k) Number K992370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1999
Decision Date September 20, 1999
Days to Decision 67 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
22d faster than avg
Panel avg: 89d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.