Cleared Traditional

K992370 - AMPLAID A724 AND A728

K992370 is an FDA 510(k) clearance for AMPLAID A724 AND A728, 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 67-day FDA review.

K992370 · Amplifon S.P.A. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K992370

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 90d · This submission: 67d
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 45
Devices cleared under the same product code (ETY) and FDA review panel - the closest regulatory comparables to K992370.
GSI 2000 MIDDLE EAR ANALYZER
K000097 · Grason-Stadler, Inc. · Apr 2000
INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER
K994254 · International Distributors of Electronics For Medi · Mar 2000
PASCAL MEDICAL AB MENIETT 20
K991562 · Pascal Medical AB · Dec 1999
INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER
K990585 · Idem (Int'L Dist. of Electronics For Medicine) · May 1999
INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER
K990652 · Idem (Int'L Dist. of Electronics For Medicine) · May 1999
INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETER
K983832 · Idem (Int'L Dist. of Electronics For Medicine) · Jan 1999