AirLife™ 001904A
AirLife™ 001904A is a Class II device made by Airlife, Inc., cleared under FDA 510(k) K791819 on 26 Sep 1979 and listed in FDA GUDID since 11 Feb 2025 (UDI-DI 10889483570838), 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 | Number10889483570838 | Date11 Feb 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK791819 | Date26 Sep 1979 | StatusActive |
Official records
- AccessGUDID record 10889483570838
- FDA 510(k) database K791819
Across registries
- FDA 510(k) K791819 decided 26 Sep 1979 Active
- FDA GUDID UDI-DI 10889483570838 listed 11 Feb 2025 Listed
Timeline
- Cleared FDA 510(k) K791819
- Listed FDA GUDID 10889483570838
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- AirLife™
- Generic name
- Incentive spirometer
- Model / Ref / Catalog
- 001904A
- Primary DI / UDI-DI
- 10889483570838
- 510(k) Number
- FDA product code
- BWF
- GMDN term
- Incentive spirometer
- Device class
- Class II
- Regulation number
- 868.5690
- GUDID distribution status
- In Commercial Distribution
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