Cleared Traditional

HEARIT (K934805) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K934805 · Je Liss & Co., Inc. · Ear, Nose, Throat device
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Feb 1994
Decision
123d
Days
Class 2
Risk

K934805 is an FDA 510(k) clearance for the HEARIT. Classified as Device, Assistive Listening (product code LZI), Class II - Special Controls.

Submitted by Je Liss & Co., Inc. (Tucson, US). The FDA issued a Cleared decision on February 7, 1994 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3320 - 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 Je Liss & Co., Inc. devices

Submission Details

510(k) Number K934805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1993
Decision Date February 07, 1994
Days to Decision 123 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 89d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LZI Device, Assistive Listening
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3320
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.