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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / December 2025 / K252429

510(k) cleared

Vektor Computational ECG Mapping System (vMap®)

Vektor Medical, Inc. · Dec 4, 2025 · K252429 · In the directory

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. The company is listed in the MedDevice Startups directory.

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

Sources

In the startup directory

Vektor Medical

Cardiovascular · San Diego, CA