510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K780719Substantially Equivalent

Fungus Fighter Insoles

Combe, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K780719 is the FDA 510(k) clearance record for FUNGUS FIGHTER INSOLES, a class I device, cleared for Combe, Inc. on under FDA product code KYS (Insoles, Medical). FDA records list 3 510(k) clearances for Combe, Inc., from to . As of , FDA records show no recalls naming K780719.

Clearance record

Decision date
Received
(162 days to decision)
Product code
KYS Insoles, Medical
Regulation
21 CFR 880.6280
Device class
Class I
Review panel
General Hospital
Applicant
Combe, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KYS

Trailing 12 months

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

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