510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K851441Substantially Equivalent

Tacticon 1600

Medecon, Cupertino CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851441 is the FDA 510(k) clearance record for TACTICON 1600, cleared for Medecon on under FDA product code LRA (Hearing Aid, Tactile). FDA records list one 510(k) clearance for Medecon. As of , FDA records show no recalls naming K851441.

Clearance record

Decision date
Received
(78 days to decision)
Product code
LRA Hearing Aid, Tactile
Device class
Unclassified
Review panel
Unknown
Applicant
Medecon 21906 Hyannisport, Cupertino CA
Third party review
No

Clearances, product code LRA

Trailing 12 months

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

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