Clearance Summary
SOL-CARE IV Bag Safety Connector received FDA 510(k) clearance under submission number K202732, sponsored by Sol-Millennium Medical Group. 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 2021-11-03.
- Submission: K202732
- Applicant / Sponsor: Sol-Millennium Medical Group
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2021-11-03
Classification & Regulation
This clearance is catalogued under FDA product code LHI and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.