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THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / June 2026 / K253306

510(k) cleared

BioTracker 2.0

Biotracker, LLC · Jun 26, 2026 · K253306

FDA cleared the BioTracker 2.0 from Biotracker, LLC on Jun 26, 2026 under K253306, a traditional 510(k). The review panel was Unknown.

FDA logged the submission as received on Sep 29, 2025. The decision came 270 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Biotracker, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253306?

K253306 is the FDA 510(k) for BioTracker 2.0, submitted by Biotracker, LLC. FDA's decision date was Jun 26, 2026.

Who makes the BioTracker 2.0?

Biotracker, LLC, based in Miami, FL, is the applicant of record for K253306.

How long did the K253306 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Jun 26, 2026, 270 days later.

← All decisions in June 2026