510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K926380Substantially Equivalent for Some Indications

Alta Dressing Frame

Alta Medical Products, Inc., Sandy UT / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K926380 is the FDA 510(k) clearance record for ALTA DRESSING FRAME, a class I device, cleared for Alta Medical Products, Inc. on under FDA product code KMF (Bandage, Liquid). FDA records list one 510(k) clearance for Alta Medical Products, Inc. As of , FDA records show no recalls naming K926380.

Clearance record

Decision date
Received
(227 days to decision)
Product code
KMF Bandage, Liquid
Regulation
21 CFR 880.5090
Device class
Class I
Review panel
General Hospital
Applicant
Alta Medical Products, Inc. 8378 Azul Way, Sandy UT
Third party review
No

Clearances, product code KMF

Trailing 12 months

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

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