Beyond Air, Inc.: FDA clearances and approvals
Beyond Air, Inc. has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel. It is the industry lead sponsor of 2 device clinical trials on ClinicalTrials.gov. It files with the SEC as Beyond Air, Inc. (XAIR).
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QTB | Nitric Oxide Generator And Delivery System | 1 | 0 |
Review panels
- Anesthesiology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P200044 | PMA | LungFit PH | 2022-06-28 |
Recalls
openFDA lists no recalls under a recalling firm named Beyond Air, 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
Beyond Air, Inc. is the industry lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04685720: A Pilot Study to Assess the Effect of Intermittent iNO on the Treatment of NTM Lung Infection in CF and Non-CF Patients (Completed, started 2020-12-07)
- NCT04606407: Inhaled NO for the Treatment of Viral Pneumonia in Adults (Completed, started 2020-11-25)
SEC filings
Beyond Air, Inc. (XAIR): EDGAR filings, CIK 1641631. Matched by exact company name.
Frequently asked questions
How many FDA 510(k) clearances does Beyond Air, Inc. have?
Beyond Air, Inc. has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel.
What devices does Beyond Air, Inc. make?
Its most frequent FDA product codes are QTB (Nitric Oxide Generator And Delivery System, 1).
Has Beyond Air, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Beyond Air, Inc. Related entities may recall under other names.
Next steps
- See all 0 Beyond Air, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QTB, Beyond Air, 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.