NxStage PureFlow Solution
FDA 510(k) K233213 · Nxstage Medical, Inc.
510(k) numberK233213
Submission
- Device name
- NxStage PureFlow Solution
- Applicant
- Nxstage Medical, Inc.
Lawrence, MA, US - Received
- September 28, 2023
- Decision date
- January 18, 2024
- 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 |
| 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 |
| K202508 | Hemo-Lyte C CartridgeKPO · Traditional | Di-Chem, Inc. | 08/12/2022SE |
More from Di-Chem, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K232803 | NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)KDI · Traditional | 03/14/2024SE |
| K230632 | VersiHD with GuideMe softwareKDI · Traditional | 08/11/2023SE |
| K183158 | NxStage Cartridge Express with SpeedswapKDI · Traditional | 08/09/2019SE |
| K181991 | NxStage Connected Health SystemFKP · Traditional | 09/26/2018SE |
| K171331 | NxStage System OneKDI · Traditional | 08/24/2017SE |
| K170469 | NxStage System One PlusKDI · Traditional | 05/09/2017SE |
| K150472 | NxStage System OneODN · Special | 06/04/2015SE |
| K143313 | NxStage Therapeutic Plasma Exchange (TPE) CartridgeKDI · Traditional | 03/20/2015SE |
| K141752 | Nxstage System OneODN · Traditional | 12/19/2014SE |
| K134019 | Medisystems Onesite Dual Lumen Needle with Masterguard Anti-Stick Needle Protector…FIE · Traditional | 09/11/2014SE |
Questions and answers
When was NxStage PureFlow Solution cleared by the FDA?
NxStage PureFlow Solution (K233213) received a 510(k) decision of Substantially Equivalent on January 18, 2024, 112 days after the submission was received.
What is the product code of K233213?
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.