FDA applicant
Acacia, Inc.
FDA records 17 decisions for Acacia, Inc. (Loma Linda, CA) from 1979 to 2014: 17 510(k) clearances. Most are in product codes LHI (Set, I.V. Fluid Transfer) and FMF (Syringe, Piston). Its devices cite 14 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Acacia, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2014
2026 so far, outlined.
Recalls per year
1in 2015
Class I Class II/III not classified
Planning a device like Acacia, Inc.’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) ReportOther applicant names beginning “Acacia”
FDA records each applicant name separately; these may or may not be the same firm.