BioTracker 2.0— 510(k) K253306
Substantially EquivalentBiotracker, LLC
FDA 510(k) clearance K253306 for BioTracker 2.0, Substantially Equivalent on 2026-06-26. Applicant: Biotracker, LLC.
Summary
BioTracker 2.0 is from Biotracker, LLC. This record gives no product code, device class, or regulation number, and it doesn't describe the device beyond its name.
The classification panel is listed as Unknown, and the Cardiovascular review panel handled it as a Traditional 510(k).
Biotracker filed from Miami, Florida. Review took 270 calendar days (September 29, 2025 to June 26, 2026).
Clearance details
- Applicant
- Biotracker, LLC
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.