Clearance Summary
Smart Check O2 (MA0236) received FDA 510(k) clearance under submission number K250002, sponsored by Life Spark Medical, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2025-04-24.
- Submission: K250002
- Applicant / Sponsor: Life Spark Medical, LLC
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1720
- Decision date: 2025-04-24
Classification & Regulation
This clearance is catalogued under FDA product code CCL and 21 CFR 868.1720, within the Anesthesiology review panel as a Class II device.