510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911120Substantially Equivalent

Decontaminating Machines, Ls-850, Ls-76, Dw/t-216, T-21

Hamo USA, Inc., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911120 is the FDA 510(k) clearance record for DECONTAMINATING MACHINES, LS-850, LS-76, DW/T-216, T-21, a class II device, cleared for Hamo USA, Inc. on under FDA product code MEC (Disinfector, Medical Devices). FDA records list one 510(k) clearance for Hamo USA, Inc. As of , FDA records show no recalls naming K911120.

Clearance record

Decision date
Received
(1,060 days to decision)
Product code
MEC Disinfector, Medical Devices
Regulation
21 CFR 880.6992
Device class
Class II
Review panel
General Hospital
Applicant
Hamo USA, Inc. 10100 NW 116th Way, Suite 14, Miami FL
Third party review
No

Clearances, product code MEC

Trailing 12 months

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

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