Prismasate Dialysis Solutions for Continuius Renal Replacement Therapy
FDA 510(k) K120333 · Gambro Renal Products
510(k) numberK120333
Submission
- Device name
- Prismasate Dialysis Solutions for Continuius Renal Replacement Therapy
- Applicant
- Gambro Renal Products
Daytona Beach, FL, US - Received
- February 3, 2012
- Decision date
- May 25, 2012
- 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 |
|---|---|---|
| K133807 | Mars Monitor Itc US, Mars Treatment Kit Type 1116/1 - X-Mars US, Prismaflex Control UnitFLD · Traditional | 03/26/2014SE |
| K131516 | Prismaflex System 7.10KDI · Traditional | 01/03/2014SE |
| K130039 | Revaclear 300 Dialyzer, Revaclear 400 DialyzerKDI · Traditional | 05/02/2013SE |
| K113313 | Molecular Adsorbent Recirculating(Mars)FLD · Traditional | 12/14/2012SE |
| K110823 | PrismaflexKDI · Traditional | 06/17/2011SE |
| K103832 | Phoenix Hemodialysis Delivery SystemKDI · Traditional | 05/20/2011SE |
| K100451 | Gamcath High Flow Dolphin MS-GDHC-1315 a; and MS-GDHC-1315J a, Gamcath High Flow Dolphin…MPB · Traditional | 12/21/2010SE |
| K100364 | Gambro Cartridge Blood Set Low Weight- Low Volume, Model 003422-520FJK · Traditional | 11/03/2010SE |
| K093608 | Gambro Water Purification Unit, Models Wro 300 and Wro 300 HFIP · Traditional | 07/29/2010SE |
| K080519 | Prismaflex M150 SetKDI · Traditional | 06/13/2008SE |
Questions and answers
When was Prismasate Dialysis Solutions for Continuius Renal Replacement Therapy cleared by the FDA?
Prismasate Dialysis Solutions for Continuius Renal Replacement Therapy (K120333) received a 510(k) decision of Substantially Equivalent on May 25, 2012, 112 days after the submission was received.
What is the product code of K120333?
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.