Data / Medical devices / System, Test, Breath Nitric Oxide
System, Test, Breath Nitric Oxide (MXA): 8 FDA-registered makers in 5 countries
8 establishments in 5 countries are registered with the FDA to make System, Test, Breath Nitric Oxide (product code MXA, Class 2, 21 CFR 862.3080). 5 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 15 510(k) clearances under this code, the latest on November 26, 2025, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MXA
- Device class
- 2
- Regulation
- 862.3080
- Medical specialty
- Clinical Toxicology
Makers by country
| Country | Makers |
|---|---|
| Germany | 3 |
| United Kingdom | 2 |
| Sweden | 1 |
| United States | 1 |
| Japan | 1 |
Makers of System, Test, Breath Nitric Oxide
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Niox AB | Uppsala, Sweden | Specification developer | 6 | November 22, 2017 | 0 | 0 | 0 | api.fda.gov |
| NIOX Group Plc | Oxford Oxfordshire, United Kingdom | Specification developer | 6 | November 22, 2017 | 0 | 0 | 0 | api.fda.gov |
| Medical Graphics Corp. | Saint Paul, MN, United States | Manufacturer | 2 | November 26, 2025 | 0 | 0 | 0 | api.fda.gov |
| Bedfont Scientific Ltd. | MAIDSTONE Kent, United Kingdom | Manufacturer | 1 | December 17, 2021 | 0 | 0 | 0 | api.fda.gov |
| Bosch Healthcare Solutions GMBH | Waiblingen Baden-Wurttemberg, Germany | Manufacturer | 1 | February 22, 2024 | 0 | 0 | 0 | api.fda.gov |
| Lre Medical GMBH | NOERDLINGEN Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PHC Corporation | MIMA Tokushima, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sanner GMBH | Bensheim Hesse, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 26, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.