FDA applicant
Acumed, LLC
FDA records 38 decisions for Acumed, LLC (Hillsboro, OR) from 2003 to 2025: 38 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HWC (Screw, Fixation, Bone). Since 2016 its 510(k)s took a median of 94 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 104 predicates, 18 of them its own earlier devices. 21 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Acumed, LLC’s devices, and how often a recall has named them.
FDA decisions per year
4in 2025
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Acumed, LLC’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 “Acumed”
FDA records each applicant name separately; these may or may not be the same firm.