Cleared Traditional

K971859 - EARCHECK

K971859 is an FDA 510(k) clearance for EARCHECK, manufactured by Mdi Instruments, Inc.. 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.

K971859 · Mdi Instruments, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
90d
Days
Class 2
Risk

K971859 is an FDA 510(k) clearance for the EARCHECK. Classified as Tester, Auditory Impedance (product code ETY), Class II - Special Controls.

Submitted by Mdi Instruments, Inc. (Woburn, US). The FDA issued a Cleared decision on August 18, 1997 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 Mdi Instruments, Inc. devices

FDA 510(k) Submission Details - K971859

510(k) Number K971859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1997
Decision Date August 18, 1997
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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 90d · 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 45
Devices cleared under the same product code (ETY) and FDA review panel - the closest regulatory comparables to K971859.
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K970685 · Mdi Instruments, Inc. · May 1997
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K953161 · Maico Hearing Instruments, Inc. · Jul 1995