510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K842225Substantially Equivalent

Hemodial Concentrate Mixing Apparatus

Lmf Medical Research & Manufacturing, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K842225 is the FDA 510(k) clearance record for HEMODIAL CONCENTRATE MIXING APPARATUS, a class II device, cleared for Lmf Medical Research & Manufacturing, Inc. on under FDA product code FKQ (System, Dialysate Delivery, Central Multiple Patient). FDA records list one 510(k) clearance for Lmf Medical Research & Manufacturing, Inc. As of , FDA records show no recalls naming K842225.

Clearance record

Decision date
Received
(119 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
Lmf Medical Research & Manufacturing, Inc. 803 N. Front St. Suite 3, Mchenry IL
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