FDA applicant
Riverpoint Medical
FDA records 40 decisions for Riverpoint Medical (Portland, OR) from 2009 to 2026: 40 510(k) clearances. Most are in product codes MBI (Fastener, Fixation, Nondegradable, Soft Tissue) and GAT (Suture, Nonabsorbable, Synthetic, Polyethylene). Since 2016 its 510(k)s took a median of 30 days from receipt to decision, against 58 for FDA’s reviews in the same codes and years. Its devices cite 56 predicates, 28 of them its own earlier devices. 45 recalls are linked to its devices.
FDA’s records also spell it “Riverpoint Medical, LLC”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Riverpoint Medical’s devices, and how often a recall has named them.
FDA decisions per year
4in 2025
2026 so far, outlined.
Recalls per year
1in 2023
Class I Class II/III not classified
Planning a device like Riverpoint Medical’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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