510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901377Substantially Equivalent

Barton-Mayo Tracheostoma Button

Medical Innovations International, Rochester MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901377 is the FDA 510(k) clearance record for BARTON-MAYO TRACHEOSTOMA BUTTON, a class I device, cleared for Medical Innovations International, Inc. on under FDA product code KAC (Tube, Laryngectomy). FDA records list one 510(k) clearance for Medical Innovations International, Inc. As of , FDA records show no recalls naming K901377.

Clearance record

Decision date
Received
(84 days to decision)
Product code
KAC Tube, Laryngectomy
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Medical Innovations International, Inc. 3105 NW 22nd St., Rochester MN
Third party review
No

Clearances, product code KAC

Trailing 12 months

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

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