510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K802361Substantially Equivalent

Dialyis Start Care Kit

Med-Pak Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802361 is the FDA 510(k) clearance record for DIALYIS START CARE KIT, a class I device, cleared for Med-Pak Corp. on under FDA product code FKG (Tray, Start/Stop (Including Contents), Dialysis). FDA records list 2 510(k) clearances for Med-Pak Corp., from to . As of , FDA records show no recalls naming K802361.

Clearance record

Decision date
Received
(112 days to decision)
Product code
FKG Tray, Start/Stop (Including Contents), Dialysis
Regulation
21 CFR 876.5820
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Med-Pak Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FKG

Trailing 12 months

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

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