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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 / K252429

510(k) cleared

Vektor Computational ECG Mapping System (vMap®)

Vektor Medical, Inc. · Dec 4, 2025 · K252429

FDA cleared the Vektor Computational ECG Mapping System (vMap®) from Vektor Medical, Inc. on Dec 4, 2025 under K252429, a traditional 510(k). The device falls under product code DQK, Computer, Diagnostic, Programmable, regulated at 21 CFR 870.1425 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Aug 1, 2025. The decision came 125 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 Vektor Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252429?

K252429 is the FDA 510(k) for Vektor Computational ECG Mapping System (vMap®), submitted by Vektor Medical, Inc.. FDA's decision date was Dec 4, 2025, under product code DQK (Computer, Diagnostic, Programmable).

Who makes the Vektor Computational ECG Mapping System (vMap®)?

Vektor Medical, Inc., based in San Diego, CA, is the applicant of record for K252429.

How long did the K252429 review take?

FDA received the submission on Aug 1, 2025 and issued its decision on Dec 4, 2025, 125 days later.

← All decisions in December 2025