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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 / April 2026 / K260076

510(k) cleared

SAM 3.0 Multi-Hour Continuous Ultrasound Device

ZetrOZ Systems, LLC · Apr 28, 2026 · K260076

FDA cleared the SAM 3.0 Multi-Hour Continuous Ultrasound Device from ZetrOZ Systems, LLC on Apr 28, 2026 under K260076, a special 510(k). The device falls under product code PFW, Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat, regulated at 21 CFR 890.5300 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Jan 12, 2026. The decision came 106 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 ZetrOZ Systems, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260076?

K260076 is the FDA 510(k) for SAM 3.0 Multi-Hour Continuous Ultrasound Device, submitted by ZetrOZ Systems, LLC. FDA's decision date was Apr 28, 2026, under product code PFW (Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat).

Who makes the SAM 3.0 Multi-Hour Continuous Ultrasound Device?

ZetrOZ Systems, LLC, based in Trumbull, CT, is the applicant of record for K260076.

How long did the K260076 review take?

FDA received the submission on Jan 12, 2026 and issued its decision on Apr 28, 2026, 106 days later.

← All decisions in April 2026