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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 / K253204

510(k) cleared

Catalyze

BioTissue Holdings, Inc. · Jun 5, 2026 · K253204

FDA cleared the Catalyze from BioTissue Holdings, Inc. on Jun 5, 2026 under K253204, a traditional 510(k). The device falls under product code KGN, Wound Dressing With Animal-Derived Material(S) as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Sep 26, 2025. The decision came 252 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 BioTissue Holdings, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253204?

K253204 is the FDA 510(k) for Catalyze, submitted by BioTissue Holdings, Inc.. FDA's decision date was Jun 5, 2026, under product code KGN (Wound Dressing With Animal-Derived Material(S)).

Who makes the Catalyze?

BioTissue Holdings, Inc., based in Miami, FL, is the applicant of record for K253204.

How long did the K253204 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Jun 5, 2026, 252 days later.

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