Cleared Special

K031978 - AMPLAID A756 SCREENING ADMITTANCE METER

K031978 is an FDA 510(k) clearance for AMPLAID A756 SCREENING ADMITTANCE METER, manufactured by Amplaid. The device is a Class 2 Ear, Nose, Throat device with product code ETY cleared through the Special 510(k) pathway after a 25-day FDA review.

K031978 · Amplaid · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
25d
Days
Class 2
Risk

K031978 is an FDA 510(k) clearance for the AMPLAID A756 SCREENING ADMITTANCE METER. Classified as Tester, Auditory Impedance (product code ETY), Class II - Special Controls.

Submitted by Amplaid (Deer Field, US). The FDA issued a Cleared decision on July 21, 2003 after a review of 25 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K031978

510(k) Number K031978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2003
Decision Date July 21, 2003
Days to Decision 25 days
Submission Type Special
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
65d faster than avg
Panel avg: 90d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 52
Devices cleared under the same product code (ETY) and FDA review panel - the closest regulatory comparables to K031978.
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