AQUAbase nX
FDA 510(k) K223479 · B.Braun Medical, Inc.
510(k) numberK223479
Submission
- Device name
- AQUAbase nX
- Applicant
- B.Braun Medical, Inc.
Allentown, PA, US - Received
- November 18, 2022
- Decision date
- August 16, 2023
- 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
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| 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 |
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| 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 |
| 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 |
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| K240578 | VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter SystemDTK · Traditional | 07/31/2024SE |
| K241845 | Introcan Safety® 2 IV CatheterFOZ · Special | 07/26/2024SE |
| K241385 | Omnifix Syringe NRFitQEH · Traditional | 07/13/2024SE |
| K231242 | Perifix FX Catheter; Contiplex FX CatheterBSO · Traditional | 09/15/2023SE |
| K220756 | Introcan Safety 2 IV CatheterFOZ · Special | 06/23/2022SE |
| K220626 | Introcan Safety IV CatheterFOZ · Special | 05/14/2022SE |
| K213778 | IV Administration SetFPA · Traditional | 03/03/2022SE |
Questions and answers
When was AQUAbase nX cleared by the FDA?
AQUAbase nX (K223479) received a 510(k) decision of Substantially Equivalent on August 16, 2023, 271 days after the submission was received.
What is the product code of K223479?
The FDA product code is FIP – Subsystem, Water Purification, a Class II (moderate risk) device regulated under 21 CFR 876.5665.