Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hemodia Sas — 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) |
|---|---|---|---|---|---|
| K221919 | DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets | Hemodia Sas | 2023-03-09 | 251 | 0 |
| K203480 | DOUBLEFLO system | Hemodia Sas | 2021-04-05 | 129 | 0 |
| K192921 | Zeos Aqua Vision Pump and tube | Hemodia Sas | 2020-10-09 | 359 | 0 |
| K132883 | HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS) | Hemodia Sas | 2013-11-01 | 49 | 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