Longeviti Neuro Solutions, LLC: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Longeviti Neuro Solutions, LLC” (first 2018, latest 2026), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 69 days. Since 2017 the median was 69 days, against 126 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 1 | 406 |
| 2019 | 0 | — |
| 2020 | 3 | 33 |
| 2021 | 3 | 59 |
| 2022 | 0 | — |
| 2023 | 1 | 133 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 113 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Longeviti Neuro Solutions, LLC took a median 69 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 126 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 8 | 8 |
| KKY | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction | 1 | 1 |
Review panels
Most recent Longeviti Neuro Solutions, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260709 | ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754) | GXN | 2026-06-25 | 113 |
| K231920 | Longeviti ClearFit OTS Cranial Implant | GXN | 2023-11-09 | 133 |
| K212058 | Longeviti ClearFit OTS Cranial Implants | GXN | 2021-09-08 | 69 |
| K211514 | Longeviti PorousFit implant | KKY | 2021-07-15 | 59 |
| K210616 | Longeviti PMMA Static Cranial Implant | GXN | 2021-03-31 | 30 |
| K203349 | Longeviti ClearFit Cranial Implant | GXN | 2020-12-16 | 33 |
| K202901 | Longeviti ClearFit Cranial Implant | GXN | 2020-10-30 | 31 |
| K191210 | Longeviti ClearFit Cranial Implant | GXN | 2020-01-09 | 248 |
| K170410 | Longeviti PMMA Static Cranial Implant | GXN | 2018-03-23 | 406 |
Recalls
openFDA lists no recalls under a recalling firm named Longeviti Neuro Solutions, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Longeviti Neuro Solutions, LLC?
FDA lists 9 510(k) clearances under the applicant name “Longeviti Neuro Solutions, LLC” (first 2018, latest 2026), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Longeviti Neuro Solutions, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Longeviti Neuro Solutions, LLC is 69 days. Since 2017: 69 days, versus 126 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Longeviti Neuro Solutions, LLC?
The most frequent FDA product codes under this applicant name are GXN (Plate, Cranioplasty, Preformed, Non-Alterable, 8); KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction, 1).
Next steps
- See all 9 Longeviti Neuro Solutions, LLC clearances with predicates and recalls
- Run predicate analysis for product code GXN, Longeviti Neuro Solutions, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.