# Vivonic GmbH

- Location (FDA's records): Sailauf, DE
- FDA decisions: 2 (2014–2015): 2 510(k) clearances
- Product codes: FIP (2)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Gambro Healthcare: 1 (https://510kreport.com/company/gambro-healthcare)
- Lauer Membran Wassertechnik GmbH: 1 (https://510kreport.com/company/lauer-membran-wassertechnik)
- Mar Cor Purification, Inc.: 1 (https://510kreport.com/company/mar-cor-purification)
- Gambro Renal Products: 1 (https://510kreport.com/company/gambro-renal-products)

## Firms that cite its devices most
- Fresenius Medical Care Renal Therapies Group, LLC: 2 (https://510kreport.com/company/fresenius-medical-care-renal-therapies-group)
- Fresenius Medical Care Rental Therapies Group, LLC: 1 (https://510kreport.com/company/fresenius-medical-care-rental-therapies-group)

## Its most-cited devices
- K133829: Aquabplus,Aquabplus & Aquabplus B2,Aquabplus&Aquabplus HF,Aquabplus& Aquabplus B2& Aquablus HF (2014), cited by 2
- K143617: AquaC UNO H (2015), cited by 1

## Recent decisions
- K143617: AquaC UNO H (Oct 19, 2015)
- K133829: Aquabplus,Aquabplus & Aquabplus B2,Aquabplus&Aquabplus HF,Aquabplus& Aquabplus B2& Aquablus HF (Apr 22, 2014)

Source page: https://510kreport.com/company/vivonic