Cleared Traditional

K872645 - AIR CONDUCTION IN-THE-EAR HEARING AID UA/115/SCR (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K872645 · Richards Medical Co., Inc. · Ear, Nose, Throat device
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Dec 1987
Decision
155d
Days
Class 1
Risk

K872645 is an FDA 510(k) clearance for the AIR CONDUCTION IN-THE-EAR HEARING AID UA/115/SCR. Classified as Face Plate Hearing Aid (product code LRB), Class I - General Controls.

Submitted by Richards Medical Co., Inc. (Memphis, US). The FDA issued a Cleared decision on December 8, 1987 after a review of 155 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 Richards Medical Co., Inc. devices

Submission Details

510(k) Number K872645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1987
Decision Date December 08, 1987
Days to Decision 155 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
66d slower than avg
Panel avg: 89d · This submission: 155d
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.