Identifiers
- 510(k) Number
- K232953 FDA 510(k)
- FDA Product Code
- FIP FDA 510(k)
- Models / Variants
- AquaBplus FDA 510(k)AquaB LITE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5665 FDA 510(k)
- Regulation Number
- 876.5665 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The AquaBplus and AquaB LITE are modular reverse osmosis water purification systems intended for use with hemodialysis systems. They remove organic and inorganic substances and microbial contaminants from water used for treating hemodialysis patients or related therapies. The systems operate using pretreated soft water as a feed source to produce dialysis-quality water.
These devices are supplied as water purification subsystems and are intended for integration into clinical hemodialysis settings. The product family includes multiple models: AquaB LITE and AquaBplus, with variants such as 500 and 1000 and 1500 configurations. The systems are regulated under product code FIP and device class 2, with a traditional 510(k) clearance pathway. Storage and handling conditions are not specified in the available data.
Frequently asked questions
What is the AquaBplus and AquaB LITE used for?
These systems are modular reverse osmosis water purification units intended for use with hemodialysis machines. They treat water by removing organic and inorganic substances as well as microbial contaminants, ensuring dialysis-quality water for patient therapies.
How are the AquaBplus and AquaB LITE supplied?
They are provided as water purification subsystems designed for integration into clinical hemodialysis environments. The product family includes multiple models such as AquaB LITE and AquaBplus, with configuration variants like 500, 1000, and 1500.
What feed water source is required for these systems?
The systems require pretreated soft water as a feed source. This preconditioned water is then processed through reverse osmosis to produce water meeting dialysis quality standards.
Are there any specified storage or handling conditions for these units?
No specific storage or handling conditions are documented in the available regulatory data for the AquaBplus and AquaB LITE systems.
What regulatory pathway was used for clearance of these devices?
The AquaBplus and AquaB LITE were cleared through the traditional 510(k) premarket notification pathway under product code FIP, with a determination of substantial equivalence to a predicate device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: AquaB LITE: Dialysis Water Treatment System, Fresenius Medical Care AquaBplus Instructions For Use Manual, AquaBplus; AquaB LITE (K232953) — FDA 510 (k) | Innolitics, PDF June 13, 2024 Fresenius Medical Care Renal Therapies Group, LLC Greg ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232953 | Class II | Active |
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Manufacturer
- Manufacturer
- Fresenius Medical Care Renal Therapies Group, LLC
Sources (1)
- FDA 510(k) K232953 24 fields · synced Sep 22, 2026