Neurophet., Inc.: FDA clearances and approvals
Neurophet., Inc. has 6 FDA 510(k) clearances (first 2022, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time: 131 days. Since 2017 its median was 131 days, against 131 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 2 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2022 | 1 | 81 |
| 2023 | 1 | 448 |
| 2024 | 1 | 88 |
| 2025 | 0 | — |
| 2026 | 3 | 174 |
Review time against the same product codes
Since 2017, Neurophet., Inc.'s cleared 510(k)s took a median 131 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 131 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QIH | Automated Radiological Image Processing Software | 4 | 4 |
| LLZ | System, Image Processing, Radiological | 2 | 2 |
Review panels
- Radiology (6)
Most recent Neurophet., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261273 | Neurophet AQUA | QIH | 2026-05-15 | 28 |
| K252563 | Neurophet SCALE PET | QIH | 2026-05-15 | 274 |
| K252496 | Neurophet AQUA AD Plus | QIH | 2026-01-29 | 174 |
| K242215 | Neurophet AQUA (V3.1) | QIH | 2024-10-25 | 88 |
| K220437 | Neurophet AQUA | LLZ | 2023-05-10 | 448 |
| K221405 | Neurophet SCALE PET | LLZ | 2022-08-05 | 81 |
Recalls
openFDA lists no recalls under a recalling firm named Neurophet., Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Neurophet., Inc. is the industry lead sponsor of 2 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT07417540: Evaluation of SCALE PET Software for Quantitative Brain PET Analysis in Alzheimer's Disease (Completed, started 2025-06-02)
- NCT06305949: Clinical Trial on the Safety and Efficacy of Optimized Transcranial Direct Current Stimulation for the Swallowing Function in Patients With Post-Stroke Dysphagia (Recruiting, started 2024-04-22)
Frequently asked questions
How many FDA 510(k) clearances does Neurophet., Inc. have?
Neurophet., Inc. has 6 FDA 510(k) clearances (first 2022, latest 2026), across 2 product codes in 1 review panel.
How long does FDA take to clear Neurophet., Inc.'s 510(k)s?
The median time from FDA receipt to decision across Neurophet., Inc.'s cleared 510(k)s is 131 days. Since 2017: 131 days, versus 131 days for all cleared 510(k)s in the same product codes.
What devices does Neurophet., Inc. make?
Its most frequent FDA product codes are QIH (Automated Radiological Image Processing Software, 4); LLZ (System, Image Processing, Radiological, 2).
Has Neurophet., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Neurophet., Inc. Related entities may recall under other names.
Next steps
- See all 6 Neurophet., Inc. clearances with predicates and recalls
- Run predicate analysis for product code QIH, Neurophet., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.