AquaC UNO H
FDA 510(k) K250471 · Fresenius Medical Care Renal Therapies Group, LLC
510(k) numberK250471
Submission
- Device name
- AquaC UNO H
- Applicant
- Fresenius Medical Care Renal Therapies Group, LLC
Waltham, MA, US - Received
- February 18, 2025
- Decision date
- November 14, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FIP – Subsystem, Water Purification
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5665
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FIP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251851 | DIASAFEplusUS (F00013010)FIP · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 10/09/2025SE |
| K252181 | AquaAFIP · Traditional | Fresenius Medical Care North America | 09/09/2025SE |
| K250514 | UPT Series Medical RO Water Treatment SystemFIP · Special | Specialty Water Technologies, Inc. | 03/17/2025SE |
| K232953 | AquaBplus; AquaB LITEFIP · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 06/13/2024SE |
| K223479 | AQUAbase nXFIP · Traditional | B.Braun Medical, Inc. | 08/16/2023SE |
| K231410 | RenaPure Endotoxin Retentive FilterFIP · Traditional | Evoqua Water Technologies, LLC | 07/19/2023SE |
| K223656 | AmeriWater MediQA Reverse Osmosis System (MSP3HF)FIP · Special | AmeriWater, LLC | 02/13/2023SE |
| K213507 | AquaAFIP · Traditional | Fresenius Medical Care Rental Therapies Group, LLC | 07/27/2022SE |
| K211035 | U9000 Plus UltrafilterFIP · Traditional | Baxter Healthcare Corporation | 10/19/2021SE |
| K200670 | EON Portable RO Water Purification SystemFIP · Special | Mar Cor Purification, Inc. | 04/16/2020SE |
More from Mar Cor Purification, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261267 | Careflux H60;Careflux H70;Careflux V500KDI · Traditional | 07/24/2026SE |
| K252377 | NxStage System One with NxViewKDI · Traditional | 05/15/2026SE |
| K252459 | multiFlux 130 (F00013123); multiFlux 160 (F00013124)KDI · Traditional | 02/10/2026SE |
| K253462 | NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)KPO · Traditional | 01/29/2026SE |
| K253518 | FX CorAL 40; FX CorAL 50KDI · Special | 12/18/2025SE |
| K250634 | BCM2-Body Composition MonitorDSB · Traditional | 11/24/2025SE |
| K251851 | DIASAFEplusUS (F00013010)FIP · Traditional | 10/09/2025SE |
| K252180 | Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby…KPO · Traditional | 09/09/2025SE |
| K243237 | 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T…KDI · Traditional | 06/13/2025SE |
| K243505 | 5008X Hemodialysis SystemKDI · Traditional | 05/30/2025SE |
Questions and answers
When was AquaC UNO H cleared by the FDA?
AquaC UNO H (K250471) received a 510(k) decision of Substantially Equivalent on November 14, 2025, 269 days after the submission was received.
What is the product code of K250471?
The FDA product code is FIP – Subsystem, Water Purification, a Class II (moderate risk) device regulated under 21 CFR 876.5665.