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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 / September 2025 / K251275

510(k) cleared

VitalStream ART Connect; VitalStream-Hemo

Caretaker Medical · Sep 26, 2025 · K251275

FDA cleared the VitalStream ART Connect; VitalStream-Hemo from Caretaker Medical on Sep 26, 2025 under K251275, a traditional 510(k). The device falls under product code DXG, Computer, Diagnostic, Pre-Programmed, Single-Function, regulated at 21 CFR 870.1435 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Apr 24, 2025. The decision came 155 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 Caretaker Medical in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251275?

K251275 is the FDA 510(k) for VitalStream ART Connect; VitalStream-Hemo, submitted by Caretaker Medical. FDA's decision date was Sep 26, 2025, under product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function).

Who makes the VitalStream ART Connect; VitalStream-Hemo?

Caretaker Medical, based in Charlottesville, VA, is the applicant of record for K251275.

How long did the K251275 review take?

FDA received the submission on Apr 24, 2025 and issued its decision on Sep 26, 2025, 155 days later.

← All decisions in September 2025