Cleared Traditional

RELIABLE (K834479) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K834479 · Reliable Hearing Aide · Ear, Nose, Throat device
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Jul 1984
Decision
204d
Days
Class 1
Risk

K834479 is an FDA 510(k) clearance for the RELIABLE. Classified as Face Plate Hearing Aid (product code LRB), Class I - General Controls.

Submitted by Reliable Hearing Aide. The FDA issued a Cleared decision on July 11, 1984 after a review of 204 days - an extended review cycle.

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 Reliable Hearing Aide devices

Submission Details

510(k) Number K834479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1983
Decision Date July 11, 1984
Days to Decision 204 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d slower than avg
Panel avg: 89d · This submission: 204d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LRB Face Plate Hearing Aid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.3300
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.