510(k) Report

FDA applicant

Xvivo Perfusion AB

Englewood5 decisions2010–20261 recall

FDA records 5 decisions for Xvivo Perfusion AB (Englewood) from 2010 to 2026: 4 510(k) clearances and 1 original PMA approval. Most are in product codes KDN (System, Perfusion, Kidney) and PHO (Normothermic Preservation System For…). Its devices cite 5 predicates, 2 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Xvivo Perfusion, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Xvivo Perfusion AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2010: 12018: 12019: 12022: 12026 (partial year): 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2022

2022: 1
2010high 1 (2022) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Xvivo Perfusion AB by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KDNSystem, Perfusion, Kidney4decisions
  • PHONormothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs1decision

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K091989Perfadex and Perfadex with ThamXvivo Perfusion AB · 20104cite it
  • K170826Perfadex PlusXvivo Perfusion AB · 20182cite it

What has FDA decided for it lately?

  • K261644Perfadex PlusXvivo Perfusion AB · 2026
  • K211333KIDNEY ASSIST-transportXvivo Perfusion AB · 2022
  • P180014XPS™ with Steen Solution™ PerfusateXvivo Perfusion, Inc. · 20191 recall
  • K170826Perfadex PlusXvivo Perfusion AB · 2018
  • K091989Perfadex and Perfadex with ThamXvivo Perfusion AB · 2010

All 4 as Xvivo Perfusion AB →The one decision as Xvivo Perfusion, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • P180014XVIVO Organ Chamber REF 19020Apr 8, 2022Class II