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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 / K252337

510(k) cleared

EdgeFlow Gel Pad

Edgecare, Inc. · Apr 24, 2026 · K252337

FDA cleared the EdgeFlow Gel Pad from Edgecare, Inc. on Apr 24, 2026 under K252337, a traditional 510(k). The device falls under product code MUI, Media, Coupling, Ultrasound, regulated at 21 CFR 892.1570 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jul 28, 2025. The decision came 270 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: K252237 (EdgeFlow UW20).

Questions & Answers

What did FDA clear under K252337?

K252337 is the FDA 510(k) for EdgeFlow Gel Pad, submitted by Edgecare, Inc.. FDA's decision date was Apr 24, 2026, under product code MUI (Media, Coupling, Ultrasound).

Who makes the EdgeFlow Gel Pad?

Edgecare, Inc., based in Seoul, is the applicant of record for K252337.

How long did the K252337 review take?

FDA received the submission on Jul 28, 2025 and issued its decision on Apr 24, 2026, 270 days later.

← All decisions in April 2026