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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 / July 2026 / K260700

510(k) cleared

BlueDop Vascular Expert

BlueDop Medical, Ltd. · Jul 8, 2026 · K260700

FDA cleared the BlueDop Vascular Expert from BlueDop Medical, Ltd. on Jul 8, 2026 under K260700, a traditional 510(k). The device falls under product code DPW, Flowmeter, Blood, Cardiovascular, regulated at 21 CFR 870.2100 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Mar 4, 2026. The decision came 126 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 BlueDop Medical, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260700?

K260700 is the FDA 510(k) for BlueDop Vascular Expert, submitted by BlueDop Medical, Ltd.. FDA's decision date was Jul 8, 2026, under product code DPW (Flowmeter, Blood, Cardiovascular).

Who makes the BlueDop Vascular Expert?

BlueDop Medical, Ltd., based in London, is the applicant of record for K260700.

How long did the K260700 review take?

FDA received the submission on Mar 4, 2026 and issued its decision on Jul 8, 2026, 126 days later.

← All decisions in July 2026