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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 / October 2026 / K253717

510(k) cleared

Helo Return

Endovascular Engineering, Inc. · Oct 11, 2026 · K253717 · In the directory

FDA cleared the Helo Return from Endovascular Engineering, Inc. on Oct 11, 2026 under K253717, a traditional 510(k). The device falls under product code CAC, Apparatus, Autotransfusion, regulated at 21 CFR 868.5830 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Nov 24, 2025. The decision came 321 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: K261800 (Helo Max Thrombectomy System (HEL2090)), K252956 (Helo Thrombectomy System).

Questions & Answers

What did FDA clear under K253717?

K253717 is the FDA 510(k) for Helo Return, submitted by Endovascular Engineering, Inc.. FDA's decision date was Oct 11, 2026, under product code CAC (Apparatus, Autotransfusion).

Who makes the Helo Return?

Endovascular Engineering, Inc., based in Menlo Park, CA, is the applicant of record for K253717. The company is listed in the MedDevice Startups directory.

How long did the K253717 review take?

FDA received the submission on Nov 24, 2025 and issued its decision on Oct 11, 2026, 321 days later.

← All decisions in October 2026

Sources

In the startup directory

E2 (Endovascular Engineering)

Cardiovascular · Menlo Park, CA