# K223479: AQUAbase nX

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Aug 16, 2023 after 271 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: 4 generations back to K811678 (1981). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K124059: Aquaboss Ecoro Dia I (HT); Aquaboss Ecoro Dia II (HT), Lauer Membran Wassertechnik GmbH (2013) Summary page 5.

## Indications for use
The AQUAbase nX is intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients. The AQUAbase nX is to be used at dialysis clinics or hospitals The AQUAbase nX is a reverse osmosis unit intended to be a component in a complete water purification system, and is not a complete water treatment system. This reverse osmosis unit must be preceded by pre-treatment devices. Whether a particular device is included in an individual water treatment system will be dictated by local conditions. The reverse osmosis unit may need to be followed by post-treatment devices as well. The AQUAbase nX is designed to meet current AAMI/ISO and Federal (U.S.) standards.

Source page: https://510kreport.com/device/K223479
Methodology: https://510kreport.com/methodology