510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K942651Substantially Equivalent

Biofeedback System for Speech Disorders

Casa Futura Technologies, Monte Sereno CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K942651 is the FDA 510(k) clearance record for BIOFEEDBACK SYSTEM FOR SPEECH DISORDERS, a class I device, cleared for Casa Futura Technologies on under FDA product code KTH (Device, Anti-Stammering). FDA records list one 510(k) clearance for Casa Futura Technologies. As of , FDA records show no recalls naming K942651.

Clearance record

Decision date
Received
(503 days to decision)
Product code
KTH Device, Anti-Stammering
Regulation
21 CFR 874.5840
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Casa Futura Technologies 18510 Decatur Dr., Monte Sereno CA
510(k) summary
Statement
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