Cleared Traditional

K020296 - ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057

K020296 · Apothecary Products, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Apothecary Products, Inc. devices

FDA 510(k) Submission Details - K020296

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
58d slower than avg
Panel avg: 90d · This submission: 148d
Pathway characteristics
Predicate-based equivalence.

EWD Device Classification - Class 0,

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

Regulatory Peers - EWD Protector, Hearing (insert)

Devices cleared under the same product code (EWD) and FDA review panel - the closest regulatory comparables to K020296.
SUPER SILIPLUGS EAR PLUGS
K972923 · Interview Medical Technology Corp. · Oct 1997
SILICONE PUTTY EAR PLUGS
K971517 · Bentec Medical, Inc. · Jun 1997
HEARSAVER
K962292 · Emtech Laboratories · Oct 1996
THE VIRTUAL M-332
K960500 · Virtual Corp. · Apr 1996
EAR STOPPLES FOR NOISE ATTENTION
K781907 · Crown Delta Corp. · Nov 1978