510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800445Substantially Equivalent

Edinburgh Masker

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

K800445 is the FDA 510(k) clearance record for EDINBURGH MASKER, a class I device, cleared for Foundation For Fluency, Inc. on under FDA product code KTH (Device, Anti-Stammering). FDA records list one 510(k) clearance for Foundation For Fluency, Inc. As of , FDA records show no recalls naming K800445.

Clearance record

Decision date
Received
(13 days to decision)
Product code
KTH Device, Anti-Stammering
Regulation
21 CFR 874.5840
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Foundation For Fluency, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KTH

Trailing 12 months

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

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