Flow Neuroscience AB: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Flow Neuroscience AB”, plus 1 PMA decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JXK | Cranial Electrotherapy Stimulator To Treat Depression | 1 | 0 |
Review panels
- Neurology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P230024 | PMA | Flow FL-100 | 2025-12-08 |
Recalls
openFDA lists no recalls under a recalling firm named Flow Neuroscience AB.
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 Flow Neuroscience AB is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05202119: Empower: tDCS for Major Depressive Disorder at Home (Completed, started 2022-05-12)
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.
- Flow Laboratories, Inc. (57 510(k)s)
- Flow X-Ray Corp. (2 510(k)s)
- Flow Cytometry Standards Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Flow Neuroscience AB?
FDA lists 0 510(k) clearances under the applicant name “Flow Neuroscience AB”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Flow Neuroscience AB?
The most frequent FDA product codes under this applicant name are JXK (Cranial Electrotherapy Stimulator To Treat Depression, 1).
Next steps
- See all 0 Flow Neuroscience AB clearances with predicates and recalls
- Run predicate analysis for product code JXK, Flow Neuroscience AB'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.