Rockwell Medical

Grapevine, TX, US

ROCKWELL MEDICAL appears in FDA device records in Grapevine, TX. FDA records list 6 510(k) clearances between 1999-08-05 and 2016-10-20, no PMA records and 3 registered establishments. As of 2026-09-10, FDA records show 8 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 6
PMA records: 0
Recall records: 8
Registered establishments: 3

FDA records under these names

1 name

FDA records resolved to Rockwell Medical carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Rockwell Medical Technologies, Inc.510(k), recall

510(k) clearance history

FDA records hold 6 510(k) clearances for Rockwell Medical between 1999 and 2016. The busiest year on record is 2003, with 2. The most recent is 2016, with 1.

Clearances by year, as a table

510(k) clearance decisions for Rockwell Medical, by decision year
Year	Clearances
1999	1
2002	1
2003	2
2006	1
2016	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K160847	Rockwell Medical CitraPure Acid Concetrate	KPO	Substantially Equivalent	2016-10-20
K062399	ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE	KPO	Substantially Equivalent	2006-11-17
K023985	ACIDIFIED COMPONENT CONCENTRATES FOR BICARBONATE DIALYSIS CONTAINING DI-ACETATE	KPO	Substantially Equivalent	2003-02-28
K022521	BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 GALLON	KPO	Substantially Equivalent	2003-01-03
K022500	DRI-SATE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSATE	KPO	Substantially Equivalent	2002-12-23
K983618	DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DIALYSATE CONCENTRATE	KPO	Substantially Equivalent	1999-08-05

Registered establishments

FDA registered establishments for Rockwell Medical, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
1652176	3003463852	ROCKWELL MEDICAL	4051 Freeport Pkwy Ste 100, GRAPEVINE, TX 76051 US	2026	KPO
1835498	3001236991	ROCKWELL MEDICAL	30142 WIXOM RD., WIXOM, MI 48393 US	2026	KPO
1954315	3002970979	ROCKWELL MEDICAL	308 N Iowa Ave, WASHINGTON, IA 52353 US	2026	KPO

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1869-2018	DriSate Product Code DR-145 The acid concentrate powders and liquids are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/monitor and bicarbonate concentrate.	A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch.	Class II	2018-04-07	Terminated
Z-0440-2009	SteriLyte Liquid Bicarbinate, Formula RL-01; 1 gallon (3.78 L); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051. This product is used in conjunction with C-Series RenalPure Liquid Acid Concentrate or DC-Series Dri-Sate Dry Acid Concentrate in artificial kidney (hemodialysis) machines.	Microbial growth was observed in the retain samples of 4 lots of Liquid Bicarbonate after products had been distributed.		2008-09-29	Terminated
Z-0439-2009	SteriLyte Liquid Bicarbinate, Formula CL-02; 1 gallon (3.78 L); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051. This product is used in conjunction with C-Series RenalPure Liquid Acid Concentrate or DC-Series Dri-Sate Dry Acid Concentrate in artificial kidney (hemodialysis) machines.	Microbial growth was observed in the retain samples of 4 lots of Liquid Bicarbonate after products had been distributed.		2008-09-29	Terminated
Z-0875-2008	Dri-Sate Glacial Acidic Acid (liquid component of Dri-Sate Dry Acid Concentrate DR-240); 1 quart (0.95 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051.	Foil Seal Deterioration; occuring on the tamper resistant foil seals on dialysis liquid concentrate and Dri-Sate product containers older than two years old.		2007-12-03	Terminated
Z-0874-2008	Glacial Acidic Acid (liquid component of Dri-Sate Dry Acid Concentrate DR-215); 1 quart (0.95 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051.	Foil Seal Deterioration; occuring on the tamper resistant foil seals on dialysis liquid concentrate and Dri-Sate product containers older than two years old.		2007-12-03	Terminated
Z-0873-2008	RenalPure Liquid Acid Concentrate R-259; One Gallon (3.78 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051.	Foil Seal Deterioration; occuring on the tamper resistant foil seals on dialysis liquid concentrate and Dri-Sate product containers older than two years old.		2007-12-03	Terminated
Z-0872-2008	RenalPure Liquid Acid Concentrate R-235; One Gallon (3.78 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051.	Foil Seal Deterioration; occuring on the tamper resistant foil seals on dialysis liquid concentrate and Dri-Sate product containers older than two years old.		2007-12-03	Terminated
Z-0871-2008	RenalPure Liquid Acid Concentrate R-006; One Gallon (3.78 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051.	Foil Seal Deterioration; occuring on the tamper resistant foil seals on dialysis liquid concentrate and Dri-Sate product containers older than two years old.		2007-12-03	Terminated

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain