FDA applicant
Haemonetics Corp.
FDA records 36 decisions for Haemonetics Corp. (Braintree, MA) from 1980 to 2025: 36 510(k) clearances. Most are in product codes CAC (Apparatus, Autotransfusion) and JPA (System, Multipurpose For In Vitro Coagulation…). Since 2016 its 510(k)s took a median of 103 days from receipt to decision, against 74 for FDA’s reviews in the same codes and years. Its devices cite 19 predicates, 10 of them its own earlier devices. 29 recalls are linked to its devices.
FDA’s records also spell it “Haemonetics Corporation”, “Haemonetics”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Haemonetics Corp.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
1in 2020
Class I Class II/III not classified
Planning a device like Haemonetics Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report