Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Haemotronic, Inc. — 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) |
|---|---|---|---|---|---|
| K921597 | CAVH/CVVH/CAVHD SET MODEL #HT-HF/505 | Haemotronic, Inc. | 1995-02-24 | 1057 | 0 |
| K921595 | Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2 | Haemotronic, Inc. | 1992-12-24 | 265 | 0 |
| K921594 | HAEMOTROL MODEL #HT-SB/6 BURETTE SET | Haemotronic, Inc. | 1992-12-24 | 265 | 0 |
| K913361 | DRAIN/PRIMING/RECIRCULATION BAG | Haemotronic, Inc. | 1992-03-30 | 245 | 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