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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 / K252237

510(k) cleared

EdgeFlow UW20

Edgecare, Inc. · Apr 17, 2026 · K252237

FDA cleared the EdgeFlow UW20 from Edgecare, Inc. on Apr 17, 2026 under K252237, a traditional 510(k). The device falls under product code IYO, System, Imaging, Pulsed Echo, Ultrasonic, regulated at 21 CFR 892.1560 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jul 17, 2025. The decision came 274 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Edgecare, Inc. has one other decision in the tracker over the last 12 months: K252337 (EdgeFlow Gel Pad).

Questions & Answers

What did FDA clear under K252237?

K252237 is the FDA 510(k) for EdgeFlow UW20, submitted by Edgecare, Inc.. FDA's decision date was Apr 17, 2026, under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic).

Who makes the EdgeFlow UW20?

Edgecare, Inc., based in Seoul, is the applicant of record for K252237.

How long did the K252237 review take?

FDA received the submission on Jul 17, 2025 and issued its decision on Apr 17, 2026, 274 days later.

← All decisions in April 2026

Sources