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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 / August 2026 / K260211

510(k) cleared

Dashboard (P007000)

Hill-Rom, Inc. · Aug 13, 2026 · K260211

FDA cleared the Dashboard (P007000) from Hill-Rom, Inc. on Aug 13, 2026 under K260211, a traditional 510(k). The device falls under product code MSX, System, Network And Communication, Physiological Monitors, regulated at 21 CFR 870.2300 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jan 23, 2026. The decision came 202 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 Hill-Rom, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260211?

K260211 is the FDA 510(k) for Dashboard (P007000), submitted by Hill-Rom, Inc.. FDA's decision date was Aug 13, 2026, under product code MSX (System, Network And Communication, Physiological Monitors).

Who makes the Dashboard (P007000)?

Hill-Rom, Inc., based in Batesville, IN, is the applicant of record for K260211.

How long did the K260211 review take?

FDA received the submission on Jan 23, 2026 and issued its decision on Aug 13, 2026, 202 days later.

← All decisions in August 2026