510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854391Substantially Equivalent

Hemodialysis Concentrate

Dana Laboratories, Garden Grove CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854391 is the FDA 510(k) clearance record for HEMODIALYSIS CONCENTRATE, a class II device, cleared for Dana Laboratories on under FDA product code FKQ (System, Dialysate Delivery, Central Multiple Patient). FDA records list 2 510(k) clearances for Dana Laboratories, from to . As of , FDA records show no recalls naming K854391.

Clearance record

Decision date
Received
(69 days to decision)
Product code
FKQ System, Dialysate Delivery, Central Multiple Patient
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Dana Laboratories 11697 Cardinal Cir., Garden Grove CA
Third party review
No

Clearances, product code FKQ

Trailing 12 months

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

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