510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K020296Substantially Equivalent

Adult Silicone Ear Plugs, Models # 68053, 68057

Apothecary Products, LLC, Burnsville MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K020296 is the FDA 510(k) clearance record for ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057, cleared for Apothecary Products, Inc. on under FDA product code EWD (Protector, Hearing (Insert)). FDA records list 6 510(k) clearances for Apothecary Products, Inc., from to . As of , FDA records show no recalls naming K020296.

Clearance record

Decision date
Received
(148 days to decision)
Product code
EWD Protector, Hearing (Insert)
Device class
Unclassified
Review panel
Unknown
Applicant
Apothecary Products, Inc. 11750 12th Ave. S., Burnsville MN
510(k) summary
Statement
Third party review
No

Clearances, product code EWD

Trailing 12 months

FDA records hold no clearances under product code EWD in the trailing twelve months.

FDA records show no clearances under product code EWD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EWD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260