510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K820180Substantially Equivalent

Calculi Filter Cup

Omnimedical, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820180 is the FDA 510(k) clearance record for CALCULI FILTER CUP, a class I device, cleared for Omnimedical on under FDA product code FMH (Container, Specimen, Sterile). FDA records list 6 510(k) clearances for Omnimedical, from to . As of , FDA records show no recalls naming K820180.

Clearance record

Decision date
Received
(14 days to decision)
Product code
FMH Container, Specimen, Sterile
Regulation
21 CFR 864.3250
Device class
Class I
Review panel
Pathology
Applicant
Omnimedical 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FMH

Trailing 12 months

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

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