Clearance Summary
Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set received FDA 510(k) clearance under submission number K250907, sponsored by Sol-Millennium Medical, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2025-04-30.
- Submission: K250907
- Applicant / Sponsor: Sol-Millennium Medical, Inc.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1675
- Decision date: 2025-04-30
Classification & Regulation
This clearance is catalogued under FDA product code JKA and 21 CFR 862.1675, within the Clinical Chemistry review panel as a Class II device.