Clearance Summary
AirLife Infant Heated Wire Circuit received FDA 510(k) clearance under submission number K151303, sponsored by Care Fusion. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2016-01-21.
- Submission: K151303
- Applicant / Sponsor: Care Fusion
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5270
- Decision date: 2016-01-21
Classification & Regulation
This clearance is catalogued under FDA product code BZE and 21 CFR 868.5270, within the Anesthesiology review panel as a Class II device.