Quantalx Neuroscience: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Quantalx Neuroscience” (first 2024, latest 2024), across 1 product code in 1 review panel. Median 510(k) review time under this name: 90 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 |
|---|---|---|
| 2024 | 1 | 90 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Quantalx Neuroscience took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 142 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GWF | Stimulator, Electrical, Evoked Response | 1 | 1 |
Review panels
- Neurology (1)
Most recent Quantalx Neuroscience 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242345 | Delphi Stimulator | GWF | 2024-11-05 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Quantalx Neuroscience.
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.
Device clinical trials
An industry sponsor named Quantalx Neuroscience is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT06368024: Establishment of Delphi-MD Safety Performance and Reliability (Completed, started 2023-11-28)
- NCT03884647: DELPHI in Subjects at Risk for Stroke and Dementia (Completed, started 2020-04-01)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Quantalx Neuroscience, Ltd. (1 510(k)s)
- Quantalx Neroscience (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Quantalx Neuroscience?
FDA lists 1 510(k) clearance under the applicant name “Quantalx Neuroscience” (first 2024, latest 2024), across 1 product code 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 Quantalx Neuroscience?
The median time from FDA receipt to decision across 510(k)s cleared under the name Quantalx Neuroscience is 90 days.
Which FDA product codes appear under Quantalx Neuroscience?
The most frequent FDA product codes under this applicant name are GWF (Stimulator, Electrical, Evoked Response, 1).
Next steps
- See all 1 Quantalx Neuroscience clearances with predicates and recalls
- Run predicate analysis for product code GWF, Quantalx Neuroscience'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.