# K213507: AquaA

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care Rental Therapies Group, LLC
- Decided: Jul 27, 2022 after 268 days
- Product code: FIP (Subsystem, Water Purification)
- Device class: 2
- Regulation: 21 CFR 876.5665
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K811678 (1981). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133829: Aquabplus,Aquabplus & Aquabplus B2,Aquabplus&Aquabplus HF,Aquabplus& Aquabplus B2& Aquablus HF, Vivonic GmbH (2014) Summary page 4.

## Most influential descendants
- K252181: AquaA (2025), 0 descendants of its own

## Indications for use
AquaA The AquaA water purification system is a modular reverse osmosis unit intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. This device is intended to be a component in a complete water purification system, and is not a complete water treatment system. The reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards. Visual LED Indicator The Visual LED Indicator is used to remotely monitor the operating status of a connected device (e.g., the reverse osmosis water treatment system). AquaDETECTOR (Optional) The AquaDETECTOR leakage monitoring system provides full leakage monitoring of a dialysis center, typically during non-treatment hours. The central control unit can be programed to switch off dialysis water supply systems, dialysis concentrate preparation systems, dialysis concentrate supply systems, booster pump assemblies, and pre-filtration devices when a leak is detected.

Source page: https://510kreport.com/device/K213507
Methodology: https://510kreport.com/methodology