Clearance Summary
Ambu® Virobac II® Exhalation Filter received FDA 510(k) clearance under submission number K251583, sponsored by Ambu A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2026-04-30.
- Submission: K251583
- Applicant / Sponsor: Ambu A/S
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5260
- Decision date: 2026-04-30
Classification & Regulation
This clearance is catalogued under FDA product code CAH and 21 CFR 868.5260, within the Anesthesiology review panel as a Class II device.