Cleared Traditional

K934149 - MICRO-TECH TRU CANAL

K934149 is an FDA 510(k) clearance for MICRO-TECH TRU CANAL, manufactured by Micro-Ear Technology, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K934149 · Micro-Ear Technology, Inc. · Ear, Nose, Throat device
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Dec 1993
Decision
125d
Days
Class 1
Risk

K934149 is an FDA 510(k) clearance for the MICRO-TECH TRU CANAL. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Micro-Ear Technology, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on December 27, 1993 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3300 - 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 Micro-Ear Technology, Inc. devices

FDA 510(k) Submission Details - K934149

510(k) Number K934149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1993
Decision Date December 27, 1993
Days to Decision 125 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
36d slower than avg
Panel avg: 89d · This submission: 125d
Pathway characteristics
Predicate-based equivalence.

ESD Device Classification - Class 1, General Controls

Product Code ESD Hearing Aid, Air-conduction, Prescription
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.3300
Definition An Air-conduction Hearing Aid Is A Wearable Sound Amplifying Device Intended To Compensate For Impaired Hearing That Conducts Sound To The Ear Through The Air. This Is A Prescription Hearing Aid.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ESD Hearing Aid, Air-conduction, Prescription

All 740
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K934149.
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K935265 · Miracle-Ear, Inc. · Dec 1993