# K250471: AquaC UNO H

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care Renal Therapies Group, LLC
- Decided: Nov 14, 2025 after 269 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143617: AquaC UNO H, Vivonic GmbH (2015) Summary page 5.

## Indications for use
The AquaC UNO H Portable Water Purification System is a 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. The AquaC UNO H can be connected to hemodialysis equipment used in hospitals, clinics and in home environments. 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 and FDA recognized U.S. standards.

Source page: https://510kreport.com/device/K250471
Methodology: https://510kreport.com/methodology