Clearance Summary
BioTracker 2.0 received FDA 510(k) clearance under submission number K253306, sponsored by Biotracker, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2026-06-26.
- Submission: K253306
- Applicant / Sponsor: Biotracker, LLC
- Clearance pathway: Traditional
- Review panel: Unknown
- Device class:
- Decision date: 2026-06-26
Classification & Regulation
This clearance is catalogued under FDA product code , within the Unknown review panel as a device.