Cleared Traditional

K020296 - ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057 (FDA 510(k) Clearance)

K020296 · Apothecary Products, Inc. · Ear, Nose, Throat device
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Jun 2002
Decision
148d
Days
-
Risk

K020296 is an FDA 510(k) clearance for the ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057. Classified as Protector, Hearing (insert) (product code EWD).

Submitted by Apothecary Products, Inc. (Burnsville, US). The FDA issued a Cleared decision on June 25, 2002 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel. 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.

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Submission Details

510(k) Number K020296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2002
Decision Date June 25, 2002
Days to Decision 148 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
59d slower than avg
Panel avg: 89d · This submission: 148d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EWD Protector, Hearing (insert)
Device Class -