SetPoint Medical: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “SetPoint Medical”, 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 |
|---|---|---|---|
| SFJ | Vagus Nerve Stimulator For Rheumatoid Arthritis | 1 | 0 |
Review panels
- Neurology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P240039 | PMA | SetPoint System | 2025-07-30 |
Recalls
openFDA lists no recalls under a recalling firm named SetPoint Medical.
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 SetPoint Medical is the lead sponsor of 5 device studies on ClinicalTrials.gov (3 active or recruiting). Most recent:
- NCT06796504: The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study (Recruiting, started 2026-04-17)
- NCT04539964: Vagus Nerve Stimulation for Moderate to Severe Rheumatoid Arthritis (Active not recruiting, started 2021-01-11)
- NCT04862117: Long Term Extension of Safety and Efficacy of Vagus Nerve Stimulator in Patients With Rheumatoid Arthritis (RA) (Active not recruiting, started 2018-07-28)
- NCT03437473: Safety and Efficacy of Vagus Nerve Stimulator in Patients With Rheumatoid Arthritis (RA) (Completed, started 2018-03-06)
- NCT01552941: Safety and Efficacy Vagal Nerve Stimulation in Patients With Rheumatoid Arthritis (Completed, started 2011-07)
Frequently asked questions
How many FDA 510(k) clearances are listed under SetPoint Medical?
FDA lists 0 510(k) clearances under the applicant name “SetPoint Medical”, 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 SetPoint Medical?
The most frequent FDA product codes under this applicant name are SFJ (Vagus Nerve Stimulator For Rheumatoid Arthritis, 1).
Next steps
- See all 0 SetPoint Medical clearances with predicates and recalls
- Run predicate analysis for product code SFJ, SetPoint Medical'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.