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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 / December 2025 / K252029

510(k) cleared

AI-CVD

HeartLung Corporation · Dec 19, 2025 · K252029

FDA cleared the AI-CVD from HeartLung Corporation on Dec 19, 2025 under K252029, a traditional 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jun 30, 2025. The decision came 172 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 HeartLung Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252029?

K252029 is the FDA 510(k) for AI-CVD, submitted by HeartLung Corporation. FDA's decision date was Dec 19, 2025, under product code QIH (Automated Radiological Image Processing Software).

Who makes the AI-CVD?

HeartLung Corporation, based in Houston, TX, is the applicant of record for K252029.

How long did the K252029 review take?

FDA received the submission on Jun 30, 2025 and issued its decision on Dec 19, 2025, 172 days later.

← All decisions in December 2025