# K143617: AquaC UNO H

- Pathway: 510(k) (Traditional)
- Applicant: Vivonic GmbH
- Decided: Oct 19, 2015 after 304 days
- Product code: FIP (Subsystem, Water Purification)
- Device class: 2
- Regulation: 21 CFR 876.5665
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K811678 (1981). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110578: Millenium HX Portable Reverse Osmosis Water Purification System, Mar Cor Purification, Inc. (2011) Summary page 5.
- K093608: Gambro Water Purification Unit, Models Wro 300 and Wro 300 H, Gambro Renal Products, Inc. (2010) Summary page 5.

## Most influential descendants
- K250471: AquaC UNO H (2025), 0 descendants of its own

## Recalls of this device
- May 16, 2024 · Class II · Z-2141-2024: Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard default set point range is between 4 and 18.Error message (F020104, "concentrate pressure alarm limit exceeded") concentr
- Jun 21, 2022 · Class II · Z-1769-2022: Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured
- Jun 21, 2022 · Class II · Z-1770-2022: Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured
- Jun 16, 2022 · Class II · Z-1463-2022: Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting electrical current to the
- Jun 16, 2022 · Class II · Z-1464-2022: Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting electrical current to the

## 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/K143617
Methodology: https://510kreport.com/methodology