Clearance Summary
FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) received FDA 510(k) clearance under submission number K260270, sponsored by FindAir Sp. z o.o.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2026-06-02.
- Submission: K260270
- Applicant / Sponsor: FindAir Sp. z o.o.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5630
- Decision date: 2026-06-02
Classification & Regulation
This clearance is catalogued under FDA product code CAF and 21 CFR 868.5630, within the Anesthesiology review panel as a Class II device.