510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K840182Substantially Equivalent

Renapak Concentrate Mixing Sys.

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

K840182 is the FDA 510(k) clearance record for RENAPAK CONCENTRATE MIXING SYS., a class II device, cleared for Renal Systems, Inc. on under FDA product code FKQ (System, Dialysate Delivery, Central Multiple Patient). FDA records list 35 510(k) clearances for Renal Systems, Inc., from to . As of , FDA records show no recalls naming K840182.

Clearance record

Decision date
Received
(106 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
Renal Systems, 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