AquaA
FDA 510(k) K252181 · Fresenius Medical Care North America
510(k) numberK252181
Submission
- Device name
- AquaA
- Applicant
- Fresenius Medical Care North America
Waltham, MA, US - Received
- July 11, 2025
- Decision date
- September 9, 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 |
|---|---|---|---|
| K250471 | AquaC UNO HFIP · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 11/14/2025SE |
| K251851 | DIASAFEplusUS (F00013010)FIP · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 10/09/2025SE |
| 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 |
|---|---|---|
| K162488 | Optiflux dialyzerKDI · Traditional | 04/06/2017SE |
| K152953 | Crit-Line Clip (Clic) Blood ChamberKOC · Special | 11/05/2015SE |
| K152367 | Optiflux dialyzerKDI · Traditional | 10/29/2015SE |
| K123262 | Optiflux Ultra DialyzerKDI · Traditional | 01/06/2014SE |
| K131611 | Fresenius Dry Acid Dissolution UnitsKPO · Traditional | 08/29/2013SE |
| K124035 | 2008K@HOME Hemodialysis MachineONW · Traditional | 07/03/2013SE |
| K121341 | Fresenius 2008T Hemodialysis Machine with Bibag SystemKDI · Traditional | 12/06/2012SE |
| K121599 | Crit-Line Clip (Clic)KOC · Traditional | 11/09/2012SE |
| K120017 | Fresenius 2008 Hemodiaysis Machine with Bibag SystemKDI · Special | 02/02/2012SE |
| K113427 | Fresenius 2008T Hemodialysis MachineKDI · Special | 12/21/2011SE |
Questions and answers
When was AquaA cleared by the FDA?
AquaA (K252181) received a 510(k) decision of Substantially Equivalent on September 9, 2025, 60 days after the submission was received.
What is the product code of K252181?
The FDA product code is FIP – Subsystem, Water Purification, a Class II (moderate risk) device regulated under 21 CFR 876.5665.