Cleared Traditional

BioTracker 2.0 (K253306) - FDA 510(k) Clearance

K253306 · Biotracker, LLC · Cardiovascular device
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Jun 2026
Decision
270d
Days
-
Risk

K253306 is an FDA 510(k) clearance for the BioTracker 2.0.

Submitted by Biotracker, LLC (Miami, US). The FDA issued a Cleared decision on June 26, 2026 after a review of 270 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K253306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2025
Decision Date June 26, 2026
Days to Decision 270 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 125d · This submission: 270d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -