Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Haemonetics Corporation — Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

154 daysmedian FDA review time
421 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K243858TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartrHaemonetics Corporation2025-01-15300
K232018Citrated: K, KH, RTH, FFHHaemonetics Corporation2024-03-292660
K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (Haemonetics Corporation2022-11-151540
K183160TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay CHaemonetics Corporation2019-05-091750
K160502TEG 6s Hemostasis SystemHaemonetics Corporation2017-04-194210
K162423Haemonetics Cell Saver Elite/Elite+ Autotransfusion SystemHaemonetics Corporation2017-01-031260
K160197Haemonetics Cell Saver Elite Autotransfusion SystemHaemonetics Corporation2016-05-241180

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