FDA applicant
Longeviti Neuro Solutions, LLC
FDA records 9 decisions for Longeviti Neuro Solutions, LLC (Hunt Valley, MD) from 2018 to 2026: 9 510(k) clearances. Most are in product codes GXN (Plate, Cranioplasty, Preformed, Non-Alterable) and KKY (Material, Polytetrafluoroethylene Vitreous…). Since 2016 its 510(k)s took a median of 69 days from receipt to decision, against 69 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 6 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Longeviti Neuro Solutions”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Longeviti Neuro Solutions, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2018.
Planning a device like Longeviti Neuro 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