510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K813432Substantially Equivalent

Hemodialysis System

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

K813432 is the FDA 510(k) clearance record for HEMODIALYSIS SYSTEM, a class II device, cleared for Fhk on under FDA product code FKP (System, Dialysate Delivery, Single Patient). FDA records list one 510(k) clearance for Fhk. As of , FDA records show no recalls naming K813432.

Clearance record

Decision date
Received
(197 days to decision)
Product code
FKP System, Dialysate Delivery, Single Patient
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Fhk 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FKP

Trailing 12 months

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

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