# K133829: Aquabplus,Aquabplus & Aquabplus B2,Aquabplus&Aquabplus HF,Aquabplus& Aquabplus B2& Aquablus HF

- Pathway: 510(k) (Traditional)
- Applicant: Vivonic GmbH
- Decided: Apr 22, 2014 after 126 days
- Product code: FIP (Subsystem, Water Purification)
- Device class: 2
- Regulation: 21 CFR 876.5665
- Recalls of this device: 3 (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). 8 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974899: Gambro Central Water Treatment System CWP 100 - Wro H, Gambro Healthcare (1998) Summary page 2.
- K124059: Aquaboss Ecoro Dia I (HT); Aquaboss Ecoro Dia II (HT), Lauer Membran Wassertechnik GmbH (2013) Summary page 2.

## Most influential descendants
- K213507: AquaA (2022), 1 descendant of its own
- K252181: AquaA (2025), 0 descendants of its own
- K232953: AquaBplus; AquaB LITE (2024), 0 descendants of its own

## Recalls of this device
- Aug 3, 2021 · Class II · Z-1364-2022: AquaBplus HF module on the AquaBplus 2000 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may be installed in combination with an AquaB
- Mar 18, 2021 · Class II · Z-1536-2021: AquaBplus HF module on the AquaBplus 2500 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may be installed in combination with an AquaB
- Sep 1, 2020 · Class II · Z-0098-2021: Incorrectly crimped connectors were installed on the main protective earth conductor on these machines. If the machine is moved or maintenance is performed, these crimp connections could become loose 

## Indications for use
The AquaBplus Water Purification Systems are reverse osmosis units 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. These devices are intended to be a component in a complete water purification system, and are not complete water treatment systems. Each 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.

Source page: https://510kreport.com/device/K133829
Methodology: https://510kreport.com/methodology