Nyxoah S.A.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Nyxoah S.A.”, 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 |
|---|---|---|---|
| MNQ | Stimulator, Hypoglossal Nerve, Implanted, Apnea | 1 | 0 |
Review panels
- Anesthesiology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P240024 | PMA | Genio® System 2.1 | 2025-08-08 |
Recalls
openFDA lists no recalls under a recalling firm named Nyxoah S.A..
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 Nyxoah S.A. is the lead sponsor of 4 device studies on ClinicalTrials.gov (3 active or recruiting). Most recent:
- NCT05592002: Safety and Effectiveness of the Genio® bilAteral Stimulation for Treatment of Complete Concentric CollapsE and OSA. (Active not recruiting, started 2022-12-28)
- NCT03868618: Dual-sided Hypoglossal neRvE stimulAtion for the treatMent of Obstructive Sleep Apnea (DREAM) (Active not recruiting, started 2020-10-14)
- NCT04031040: A Post-market Clinical Follow up of the Genio® System for the Treatment of Obstructive Sleep Apnea in Adults (Active not recruiting, started 2019-09-01)
- NCT03048604: BiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnoea (BLAST OSA) (Completed, started 2017-03-30)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nyxoah S.A.?
FDA lists 0 510(k) clearances under the applicant name “Nyxoah S.A.”, 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 Nyxoah S.A.?
The most frequent FDA product codes under this applicant name are MNQ (Stimulator, Hypoglossal Nerve, Implanted, Apnea, 1).
Next steps
- See all 0 Nyxoah S.A. clearances with predicates and recalls
- Run predicate analysis for product code MNQ, Nyxoah S.A.'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.