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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 / June 2026 / K260693

510(k) cleared

VicorderCS (VCS-SYS-1100)

80 Beats Medical GmbH · Jun 16, 2026 · K260693

FDA cleared the VicorderCS (VCS-SYS-1100) from 80 Beats Medical GmbH on Jun 16, 2026 under K260693, a traditional 510(k). The device falls under product code DXN, System, Measurement, Blood-Pressure, Non-Invasive, regulated at 21 CFR 870.1130 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Mar 3, 2026. The decision came 105 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 80 Beats Medical GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260693?

K260693 is the FDA 510(k) for VicorderCS (VCS-SYS-1100), submitted by 80 Beats Medical GmbH. FDA's decision date was Jun 16, 2026, under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive).

Who makes the VicorderCS (VCS-SYS-1100)?

80 Beats Medical GmbH, based in Berlin, is the applicant of record for K260693.

How long did the K260693 review take?

FDA received the submission on Mar 3, 2026 and issued its decision on Jun 16, 2026, 105 days later.

← All decisions in June 2026