Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Fresenius Hemotechnology, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K012178 | FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUE | Fresenius Hemotechnology, Inc. | 2001-07-23 | 11 | 1 |
| K984586 | FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS | Fresenius Hemotechnology, Inc. | 1999-06-29 | 187 | 0 |
| K984233 | C.A.T.S AUTOTRANSFUSION ACCESSORIES, MODELS ATS SUCTION LINE | Fresenius Hemotechnology, Inc. | 1999-02-01 | 68 | 1 |
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