# Xvivo Perfusion AB

- Location (FDA's records): Englewood
- FDA decisions: 5 (2010–2026): 4 510(k) clearances and 1 original PMA approval
- Names in FDA's records: Xvivo Perfusion AB (4); Xvivo Perfusion, Inc. (1)
- Product codes: KDN (4), PHO (1)
- Predicates its devices cite: 5 (2 its own); citations of its devices by later devices: 6 (2 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Vitrolife Sweden AB: 2 (https://510kreport.com/company/vitrolife-sweden)
- Waters Medical Systems, LLC: 1 (https://510kreport.com/company/waters-medical-systems)

## Firms that cite its devices most
- S.A.L.F. Spa: 2 (https://510kreport.com/company/salf)
- Traferox Technologies, Inc.: 1 (https://510kreport.com/company/traferox-technologies)
- United Therapeutics Corporation: 1 (https://510kreport.com/company/united-therapeutics)

## Its most-cited devices
- K091989: Perfadex and Perfadex with Tham (2010), cited by 4
- K170826: Perfadex Plus (2018), cited by 2

## Recent decisions
- K261644: Perfadex Plus (Jul 23, 2026)
- K211333: KIDNEY ASSIST-transport (Jan 20, 2022)
- P180014: XPS™ with Steen Solution™ Perfusate (Apr 26, 2019)
- K170826: Perfadex Plus (Jun 22, 2018)
- K091989: Perfadex and Perfadex with Tham (Oct 1, 2010)

Source page: https://510kreport.com/company/xvivo-perfusion