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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 / K253521

510(k) cleared

ECMT-100 WMD

Ecm Therapeutics, Inc. · Jun 18, 2026 · K253521

FDA cleared the ECMT-100 WMD from Ecm Therapeutics, Inc. on Jun 18, 2026 under K253521, 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 Nov 13, 2025. The decision came 217 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 Ecm Therapeutics, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253521?

K253521 is the FDA 510(k) for ECMT-100 WMD, submitted by Ecm Therapeutics, Inc.. FDA's decision date was Jun 18, 2026, under product code KGN (Wound Dressing With Animal-Derived Material(S)).

Who makes the ECMT-100 WMD?

Ecm Therapeutics, Inc., based in Warrendale, PA, is the applicant of record for K253521.

How long did the K253521 review take?

FDA received the submission on Nov 13, 2025 and issued its decision on Jun 18, 2026, 217 days later.

← All decisions in June 2026