510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K802690Substantially Equivalent

Ultrapak Cat. #100-0251

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

K802690 is the FDA 510(k) clearance record for ULTRAPAK CAT. #100-0251, a class I device, cleared for Occumedics, Inc. on under FDA product code HYG (Glenner'S Stain). FDA records list 2 510(k) clearances for Occumedics, Inc., from to . As of , FDA records show no recalls naming K802690.

Clearance record

Decision date
Received
(73 days to decision)
Product code
HYG Glenner'S Stain
Regulation
21 CFR 864.1850
Device class
Class I
Review panel
Hematology
Applicant
Occumedics, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HYG

Trailing 12 months

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

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