510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K022521Substantially Equivalent

Bicarbonate Dialysate Concentrate Mixer, Model 50 Gallon & 100 Gallon

Rockwell Medical, Wixom MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K022521 is the FDA 510(k) clearance record for BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 GALLON, a class II device, cleared for Rockwell Medical Technologies, Inc. on under FDA product code KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)). FDA records list 6 510(k) clearances for ROCKWELL MEDICAL, from to . As of , FDA records show 2 recalls naming K022521.

Clearance record

Decision date
Received
(157 days to decision)
Product code
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Rockwell Medical Technologies, Inc. 30142 Wixom Rd., Wixom MI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KPO

Trailing 12 months
2 clearances under product code KPO in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KPO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260