Cleared Traditional

K946108 - EAR-A-GATOR (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K946108 · Life-Tech Intl., Inc. · Ear, Nose, Throat device
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Jun 1995
Decision
181d
Days
Class 1
Risk

K946108 is an FDA 510(k) clearance for the EAR-A-GATOR. Classified as Stimulator, Caloric-air (product code KHH), Class I - General Controls.

Submitted by Life-Tech Intl., Inc. (Houston, US). The FDA issued a Cleared decision on June 13, 1995 after a review of 181 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1800 - 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 Life-Tech Intl., Inc. devices

Submission Details

510(k) Number K946108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1994
Decision Date June 13, 1995
Days to Decision 181 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
92d slower than avg
Panel avg: 89d · This submission: 181d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KHH Stimulator, Caloric-air
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.1800
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.