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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 / December 2025 / K253339

510(k) cleared

Theracor

Stimlabs, LLC · Dec 22, 2025 · K253339

FDA cleared the Theracor from Stimlabs, LLC on Dec 22, 2025 under K253339, 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 30, 2025. The decision came 83 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K253339?

K253339 is the FDA 510(k) for Theracor, submitted by Stimlabs, LLC. FDA's decision date was Dec 22, 2025, under product code KGN (Wound Dressing With Animal-Derived Material(S)).

Who makes the Theracor?

Stimlabs, LLC, based in Roswell, GA, is the applicant of record for K253339.

How long did the K253339 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Dec 22, 2025, 83 days later.

← All decisions in December 2025