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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 / August 2026 / DEN250046

510(k) cleared

Aletta® Autonomous Robotic Phlebotomy Device (ARPD) (Gen1 US)

Vitestro · Aug 19, 2026 · DEN250046 · In the directory

FDA cleared the Aletta® Autonomous Robotic Phlebotomy Device (ARPD) (Gen1 US) from Vitestro on Aug 19, 2026 under DEN250046, a direct 510(k). The device falls under product code SIW, Robotic Peripheral Venous Blood Collection System, regulated at 21 CFR 880.6975 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Sep 26, 2025. The decision came 327 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 Vitestro in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under DEN250046?

DEN250046 is the FDA 510(k) for Aletta® Autonomous Robotic Phlebotomy Device (ARPD) (Gen1 US), submitted by Vitestro. FDA's decision date was Aug 19, 2026, under product code SIW (Robotic Peripheral Venous Blood Collection System).

Who makes the Aletta® Autonomous Robotic Phlebotomy Device (ARPD) (Gen1 US)?

Vitestro, based in Utrecht, is the applicant of record for DEN250046. The company is listed in the MedDevice Startups directory.

How long did the DEN250046 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Aug 19, 2026, 327 days later.

← All decisions in August 2026