Data / Medical devices / United States / Rockwell Medical
Rockwell Medical: FDA-registered device maker in Grapevine, TX, United States, 5 510(k) clearances
Rockwell Medical is registered with the FDA (registration 1652176) in Grapevine, TX, United States. It lists 1 device type. The FDA files 5 510(k) clearances under its listings, the newest dated March 3, 2023. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1652176
- FEI number
- 3003463852
- Address
- 4051 Freeport Pkwy Ste 100, Grapevine, TX, United States, 76051
- Owner or operator
- Rockwell Medical (9030991)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- April 27, 2000
- Registered through
- 2026
- Brand names listed
- Bicarbonate Solution Concentrates for Bicarbonate Dialysis, Citrapure Acid Concentrate, Dri-Sate Acid Concentrate Mixes, HEMODIALYSIS CONCENTRATE SOLUTIONS, NikkiCart, POWDERS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | KPO | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 3, 2023 | K221652 | NIKKICART | KPO | Substantially Equivalent | Renal Care Dialysis Solutions, S.A. DE C.V. | accessdata.fda.gov |
| November 17, 2006 | K062399 | ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE | KPO | Substantially Equivalent | Rockwell Medical Technologies, Inc. | accessdata.fda.gov |
| June 16, 1998 | K981003 | ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXES | KPO | Substantially Equivalent | International Medical Products, Inc. | accessdata.fda.gov |
| June 16, 1997 | K971053 | ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSIS | KPO | Substantially Equivalent | International Medical Products, Inc. | accessdata.fda.gov |
| March 1, 1996 | K954527 | ROCKWELL MEDICAL SUPPLY LLC HEMODIALYSIS CONCENTRATE SOLUTIONS & POWDERS | KPO | Substantially Equivalent | Rockwell Medical Supply | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 29, 2008 | 49580 | Not yet classified | Terminated | 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 Concentrat | Microbial growth was observed in the retain samples of 4 lots of Liquid Bicarbonate after products had been distributed. | accessdata.fda.gov |
| December 3, 2007 | 46267 | Not yet classified | Terminated | 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. | accessdata.fda.gov |
Compare with other makers
Updated March 3, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.