Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Neurosoft , Ltd. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220254 | Neuron-Spectrum-AM with Neuron-Spectrum.NET Software | Neurosoft , Ltd. | 2022-11-30 | 303 | 0 |
| K190703 | Neuro-IOM system with Neuro-IOM.NET software | Neurosoft , Ltd. | 2021-05-22 | 796 | 0 |
| K133995 | NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE | Neurosoft , Ltd. | 2015-06-19 | 540 | 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