Clearance Summary
BD Alaris System with Guardrails Suite MX v12.1.2 received FDA 510(k) clearance under submission number K211218, sponsored by Carefusion 303, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2023-07-21.
- Submission: K211218
- Applicant / Sponsor: Carefusion 303, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2023-07-21
Classification & Regulation
This clearance is catalogued under FDA product code FRN and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.