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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 / K252956

510(k) cleared

Helo Thrombectomy System

Endovascular Engineering, Inc. · Dec 18, 2025 · K252956 · In the directory

FDA cleared the Helo Thrombectomy System from Endovascular Engineering, Inc. on Dec 18, 2025 under K252956, a traditional 510(k). The device falls under product code QEW, Peripheral Mechanical Thrombectomy With Aspiration, regulated at 21 CFR 870.5150 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 16, 2025. The decision came 93 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Endovascular Engineering, Inc. has 2 other decisions in the tracker over the last 12 months: K253717 (Helo Return), K261800 (Helo Max Thrombectomy System (HEL2090)).

Questions & Answers

What did FDA clear under K252956?

K252956 is the FDA 510(k) for Helo Thrombectomy System, submitted by Endovascular Engineering, Inc.. FDA's decision date was Dec 18, 2025, under product code QEW (Peripheral Mechanical Thrombectomy With Aspiration).

Who makes the Helo Thrombectomy System?

Endovascular Engineering, Inc., based in Menlo Park, CA, is the applicant of record for K252956. The company is listed in the MedDevice Startups directory.

How long did the K252956 review take?

FDA received the submission on Sep 16, 2025 and issued its decision on Dec 18, 2025, 93 days later.

← All decisions in December 2025

Sources

In the startup directory

E2 (Endovascular Engineering)

Cardiovascular · Menlo Park, CA