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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 / November 2025 / K250376

510(k) cleared

ViVY

Viatherm Therapeutics, LLC · Nov 5, 2025 · K250376

FDA cleared the ViVY from Viatherm Therapeutics, LLC on Nov 5, 2025 under K250376, a traditional 510(k). The device falls under product code IMJ, Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat, regulated at 21 CFR 890.5290 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Feb 10, 2025. The decision came 268 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 Viatherm Therapeutics, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250376?

K250376 is the FDA 510(k) for ViVY, submitted by Viatherm Therapeutics, LLC. FDA's decision date was Nov 5, 2025, under product code IMJ (Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat).

Who makes the ViVY?

Viatherm Therapeutics, LLC, based in Pittsburgh, PA, is the applicant of record for K250376.

How long did the K250376 review take?

FDA received the submission on Feb 10, 2025 and issued its decision on Nov 5, 2025, 268 days later.

← All decisions in November 2025