Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Neuroone Medical Technologies Corp. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251243 | OneRF Trigeminal Nerve Radiofrequency Probes | Neuroone Medical Technologies Corp. | 2025-08-15 | 115 | 0 |
| K231675 | OneRF Ablation System | Neuroone Medical Technologies Corp. | 2023-12-06 | 181 | 0 |
| K222404 | Evo® sEEG System | Neuroone Medical Technologies Corp. | 2022-10-20 | 72 | 0 |
| K211367 | Evo sEEG System | Neuroone Medical Technologies Corp. | 2021-09-01 | 120 | 0 |
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