510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K832483Substantially Equivalent

Mattress Cover, Anti-Microbial

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

K832483 is the FDA 510(k) clearance record for MATTRESS COVER, ANTI-MICROBIAL, a class I device, cleared for American Threshold Industries, Inc. on under FDA product code FMW (Cover, Mattress (Medical Purposes)). FDA records list 20 510(k) clearances for American Threshold Industries, Inc., from to . As of , FDA records show no recalls naming K832483.

Clearance record

Decision date
Received
(194 days to decision)
Product code
FMW Cover, Mattress (Medical Purposes)
Regulation
21 CFR 880.6190
Device class
Class I
Review panel
General Hospital
Applicant
American Threshold Industries, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FMW

Trailing 12 months

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

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