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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 / K254143

510(k) cleared

EM-TECH Passive Ultrasound Probe Strap

EM-TECH Solutions, Inc. · Aug 10, 2026 · K254143

FDA cleared the EM-TECH Passive Ultrasound Probe Strap from EM-TECH Solutions, Inc. on Aug 10, 2026 under K254143, a traditional 510(k). The device falls under product code ITX, Transducer, Ultrasonic, Diagnostic, regulated at 21 CFR 892.1570 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Dec 22, 2025. The decision came 231 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 EM-TECH Solutions, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254143?

K254143 is the FDA 510(k) for EM-TECH Passive Ultrasound Probe Strap, submitted by EM-TECH Solutions, Inc.. FDA's decision date was Aug 10, 2026, under product code ITX (Transducer, Ultrasonic, Diagnostic).

Who makes the EM-TECH Passive Ultrasound Probe Strap?

EM-TECH Solutions, Inc., based in Chantilly, VA, is the applicant of record for K254143.

How long did the K254143 review take?

FDA received the submission on Dec 22, 2025 and issued its decision on Aug 10, 2026, 231 days later.

← All decisions in August 2026