Rockwell Medical Supply, LLC Concentrate Solutions for Acetate Dialysate
FDA 510(k) K973253 · International Medical Products, Inc.
510(k) numberK973253
Submission
- Device name
- Rockwell Medical Supply, LLC Concentrate Solutions for Acetate Dialysate
- Applicant
- International Medical Products, Inc.
Minneapolis, MN, US - Received
- August 29, 1997
- Decision date
- October 30, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KPO – Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code KPO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260799 | Nipro Dry Acid Concentrate MixerKPO · Traditional | Nipro Technical Solutions, Incoporated | 08/19/2026SE |
| K253462 | NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)KPO · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 01/29/2026SE |
| K252180 | Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby…KPO · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 09/09/2025SE |
| K243786 | Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby…KPO · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 04/04/2025SE |
| K240920 | HemoCare Bicarbonate Concentrate Set (BCS)KPO · Traditional | Deka Research and Development | 07/12/2024SE |
| K233950 | pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW…KPO · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/10/2024SE |
| K233213 | NxStage PureFlow SolutionKPO · Traditional | Nxstage Medical, Inc. | 01/18/2024SE |
| K233159 | pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504KPO · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 12/01/2023SE |
| K223431 | Citric Complete Liquid Citric Acid ConcentrateKPO · Traditional | Nipro Renal Solutions USA, Corp. | 08/04/2023SE |
| K221652 | NikkicartKPO · Traditional | Renal Care Dialysis Solutions, S.A. DE C.V. | 03/03/2023SE |
More from Renal Care Dialysis Solutions, S.A. DE C.V.
| 510(k) | Device | Decision |
|---|---|---|
| K981003 | Rockwell Medical Supply, LLC Dri-Sate Acid Concentrate MixesKPO · Traditional | 06/16/1998SE |
| K971053 | Rockwell Medical Supply,Llc. Bicarbonate Solution Concentrates for Bicarbonate DialysisKPO · Traditional | 06/16/1997SE |
| K920077 | Nikkiso NK PumpDWD · Traditional | 09/29/1993SE |
| K923942 | Rhombo Medical Rhombo-FillKNN · Traditional | 03/24/1993SE |
| K900755 | Digital Cuff PV GaugeBSK · Traditional | 04/26/1990SE |
| K864984 | RobinjectKZE · Traditional | 06/29/1987SE |
| K863609 | Single-Patient Automatic Dialysis Unit Mod. DBB-22FKP · Traditional | 02/25/1987SE |
| K861539 | Nikkiso Infusion Pump Model PFA-02FRN · Traditional | 07/31/1986SE |
Questions and answers
When was Rockwell Medical Supply, LLC Concentrate Solutions for Acetate Dialysate cleared by the FDA?
Rockwell Medical Supply, LLC Concentrate Solutions for Acetate Dialysate (K973253) received a 510(k) decision of Substantially Equivalent on October 30, 1997, 62 days after the submission was received.
What is the product code of K973253?
The FDA product code is KPO – Dialysate Concentrate For Hemodialysis (Liquid Or Powder), a Class II (moderate risk) device regulated under 21 CFR 876.5820.