Cleared Traditional

K792428 - COE-SIL

K792428 is an FDA 510(k) clearance for COE-SIL, manufactured by Coe Laboratories, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code LDG cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K792428 · Coe Laboratories, Inc. · Ear, Nose, Throat device
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Jan 1980
Decision
57d
Days
Class 1
Risk

K792428 is an FDA 510(k) clearance for the COE-SIL. Classified as Kit, Earmold, Impression (product code LDG), Class I - General Controls.

Submitted by Coe Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 23, 1980 after a review of 57 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Coe Laboratories, Inc. devices

FDA 510(k) Submission Details - K792428

510(k) Number K792428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1979
Decision Date January 23, 1980
Days to Decision 57 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 90d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

LDG Device Classification - Class 1, General Controls

Product Code LDG Kit, Earmold, Impression
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.