Neurosoft, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Neurosoft, Inc.” (first 2000, latest 2022), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 237 days. 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 540 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 796 |
| 2022 | 1 | 303 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Neurosoft, Inc. took a median 550 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 168 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | 2 | 2 |
| OLX | Source Localization Software For Electroencephalograph Or Magnetoencephalograph | 2 | 2 |
| GWF | Stimulator, Electrical, Evoked Response | 1 | 1 |
| IKN | Electromyograph, Diagnostic | 1 | 1 |
| JXE | Device, Nerve Conduction Velocity Measurement | 1 | 1 |
Review panels
- Neurology (7)
Most recent Neurosoft, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220254 | Neuron-Spectrum-AM with Neuron-Spectrum.NET Software | OLT | 2022-11-30 | 303 |
| K190703 | Neuro-IOM system with Neuro-IOM.NET software | GWF | 2021-05-22 | 796 |
| K133995 | NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE | OLT | 2015-06-19 | 540 |
| K011241 | NEUROSOFT'S SOURCE | OLX | 2001-09-19 | 149 |
| K001781 | CURRY MULTIMODAL NEUROIMAGING SOFTWARE | OLX | 2001-02-05 | 237 |
| K001692 | NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8 | JXE | 2000-11-24 | 175 |
| K000812 | NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE) | IKN | 2000-05-17 | 65 |
Recalls
openFDA lists no recalls under a recalling firm named Neurosoft, Inc..
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 Neurosoft, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Neurosoft, Inc.” (first 2000, latest 2022), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Neurosoft, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Neurosoft, Inc. is 237 days.
Which FDA product codes appear under Neurosoft, Inc.?
The most frequent FDA product codes under this applicant name are OLT (Non-Normalizing Quantitative Electroencephalograph Software, 2); OLX (Source Localization Software For Electroencephalograph Or Magnetoencephalograph, 2); GWF (Stimulator, Electrical, Evoked Response, 1).
Next steps
- See all 7 Neurosoft, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OLT, Neurosoft, Inc.'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.