Cleared Traditional

K971747 - AMPLAID 460

K971747 is an FDA 510(k) clearance for AMPLAID 460, manufactured by Amplifon S.P.A.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K971747 · Amplifon S.P.A. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
85d
Days
Class 2
Risk

K971747 is an FDA 510(k) clearance for the AMPLAID 460. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Amplifon S.P.A. (Deer Field, US). The FDA issued a Cleared decision on August 5, 1997 after a review of 85 days - a notably fast clearance cycle.

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: 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 - K971747

510(k) Number K971747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1997
Decision Date August 05, 1997
Days to Decision 85 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
5d faster than avg
Panel avg: 90d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EWO Device Classification - Class 2, Special Controls

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 134
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K971747.
ARTICULATE FITTING SYSTEM
K973320 · Decibel Instruments, Inc. · Nov 1997
AMPLAID 171S
K972862 · Amplifon S.P.A. · Oct 1997
K 15 AUDIOMETER
K972221 · American Electromedics Corp. · Sep 1997
MAICO MA52
K971080 · Bernafon-Maico, Inc. · Jun 1997
MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT
K964132 · Bio-Logic Systems Corp. · May 1997
RACE CAR TYMPANOMETER WITH AUDIOMETER(AE-RCAUD I/QUIK TYMP 1(AE-QUIK 1)/QUICK TYMP 2(AE-QUIK 2)
K970279 · American Electromedics Corp. · Mar 1997