FDA applicant
Nanofiber Solutions, LLC
FDA records 6 decisions for Nanofiber Solutions, LLC (Dublin, OH) from 2018 to 2025: 6 510(k) clearances. Most are in product codes MAI (Fastener, Fixation, Biodegradable, Soft Tissue) and OWW (Mesh, Surgical, Absorbable, Orthopaedics…). Since 2016 its 510(k)s took a median of 29 days from receipt to decision, against 47 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 6 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Nanofiber Solutions, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Nanofiber Solutions, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2018.
Planning a device like Nanofiber Solutions, 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) Report