510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863939Substantially Equivalent

Porex(tm) Ear Prosthesis

Porex Medical, Fairburn GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863939 is the FDA 510(k) clearance record for POREX(TM) EAR PROSTHESIS, a class II device, cleared for Porex Medical on under FDA product code FZD (Prosthesis, Ear, Internal). FDA records list 15 510(k) clearances for Porex Medical, from to . As of , FDA records show no recalls naming K863939.

Clearance record

Decision date
Received
(14 days to decision)
Product code
FZD Prosthesis, Ear, Internal
Regulation
21 CFR 878.3590
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Porex Medical 500 Bohannon Rd., Fairburn GA
Third party review
No

Clearances, product code FZD

Trailing 12 months

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

FDA records show no clearances under product code FZD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FZD, 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