510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K790353Substantially Equivalent

Acute Renal Dialysis Tray

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

K790353 is the FDA 510(k) clearance record for ACUTE RENAL DIALYSIS TRAY, a class I device, cleared for Argon Medical Corp. on under FDA product code FKG (Tray, Start/Stop (Including Contents), Dialysis). FDA records list 28 510(k) clearances for Argon Medical Corp., from to . As of , FDA records show no recalls naming K790353.

Clearance record

Decision date
Received
(57 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
Argon Medical 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