Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Longeviti Neuro Solutions, LLC — Predicate Candidate Screening

8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

69 daysmedian FDA review time
406 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K231920Longeviti ClearFit OTS Cranial ImplantLongeviti Neuro Solutions, LLC2023-11-091330
K212058Longeviti ClearFitâ„¢ OTS Cranial ImplantsLongeviti Neuro Solutions, LLC2021-09-08690
K211514Longeviti PorousFit implantLongeviti Neuro Solutions, LLC2021-07-15590
K210616Longeviti PMMA Static Cranial ImplantLongeviti Neuro Solutions, LLC2021-03-31300
K203349Longeviti ClearFit Cranial ImplantLongeviti Neuro Solutions, LLC2020-12-16330
K202901Longeviti ClearFit Cranial ImplantLongeviti Neuro Solutions, LLC2020-10-30310
K191210Longeviti ClearFit Cranial ImplantLongeviti Neuro Solutions, LLC2020-01-092480
K170410Longeviti PMMA Static Cranial ImplantLongeviti Neuro Solutions, LLC2018-03-234060

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda