Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Xvivo Perfusion AB — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261644 | Perfadex Plus | Xvivo Perfusion AB | 2026-07-23 | 66 | 0 |
| K211333 | KIDNEY ASSIST-transport | Xvivo Perfusion AB | 2022-01-20 | 262 | 0 |
| K170826 | Perfadex Plus | Xvivo Perfusion AB | 2018-06-22 | 459 | 0 |
| K091989 | PERFADEX AND PERFADEX WITH THAM | Xvivo Perfusion AB | 2010-10-01 | 456 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda