NIOX VERO Filter
by Circassia AB
NIOX VERO Filter (12-1018) is a pulmonary function testing filter/mouthpiece (FDA Class II; FDA product code MXA, System,Test,Breath Nitric Oxide) made by Circassia AB, cleared under FDA 510(k) K133898 on 6 Nov 2014 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 07350047030496), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07350047030496 | Date21 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK133898 | Date6 Nov 2014 | StatusActive |
Official records
- AccessGUDID record 07350047030496
- FDA 510(k) database K133898
Across registries
- FDA 510(k) K133898 decided 6 Nov 2014 Active
- FDA GUDID UDI-DI 07350047030496 listed 21 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K133898
- Listed FDA GUDID 07350047030496
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Niox
- Generic name
- Pulmonary function testing filter/mouthpiece
- Model / Ref / Catalog
- VERO Filter, 12-1018
- Primary DI / UDI-DI
- 07350047030496
- 510(k) Number
- FDA product code
- MXA
- GMDN term
- Pulmonary function testing filter/mouthpiece
- Device class
- Class II
- Regulation number
- 862.3080
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Pulmonary function testing filter/mouthpiece.