Clearance Summary
Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min) received FDA 510(k) clearance under submission number K242735, sponsored by Belmont Medical Technologies. 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 2024-12-23.
- Submission: K242735
- Applicant / Sponsor: Belmont Medical Technologies
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2024-12-23
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.