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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 / K261569

510(k) cleared

UbiqVue 2AYe Cardiac System (UX2253)

Lifesignals, Inc. · Jul 9, 2026 · K261569

FDA cleared the UbiqVue 2AYe Cardiac System (UX2253) from Lifesignals, Inc. on Jul 9, 2026 under K261569, a traditional 510(k). The device falls under product code DRG, Transmitters And Receivers, Physiological Signal, Radiofrequency, regulated at 21 CFR 870.2910 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on May 12, 2026. The decision came 58 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Lifesignals, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261569?

K261569 is the FDA 510(k) for UbiqVue 2AYe Cardiac System (UX2253), submitted by Lifesignals, Inc.. FDA's decision date was Jul 9, 2026, under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency).

Who makes the UbiqVue 2AYe Cardiac System (UX2253)?

Lifesignals, Inc., based in Milpitas, CA, is the applicant of record for K261569.

How long did the K261569 review take?

FDA received the submission on May 12, 2026 and issued its decision on Jul 9, 2026, 58 days later.

← All decisions in July 2026