Cleared Traditional

K970685 - EARCHECK PRO

K970685 is an FDA 510(k) clearance for EARCHECK PRO, 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 93-day FDA review.

K970685 · Mdi Instruments, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
93d
Days
Class 2
Risk

K970685 is an FDA 510(k) clearance for the EARCHECK PRO. 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 May 28, 1997 after a review of 93 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 - K970685

510(k) Number K970685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1997
Decision Date May 28, 1997
Days to Decision 93 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
4d slower than avg
Panel avg: 89d · This submission: 93d
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 11
Devices cleared under the same product code (ETY) and FDA review panel - the closest regulatory comparables to K970685.
Hearing Healthcare Pro
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K905704 · Maico Hearing Instruments, Inc. · Apr 1991
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K883293 · Storz Instrument Co. · Jun 1989