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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 / June 2026 / K260482

510(k) cleared

DRE Duo

Jpi Healthcare Co, Ltd. · Jun 15, 2026 · K260482

FDA cleared the DRE Duo from Jpi Healthcare Co, Ltd. on Jun 15, 2026 under K260482, a traditional 510(k). The device falls under product code KPR, System, X-Ray, Stationary, regulated at 21 CFR 892.1680 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Feb 13, 2026. The decision came 122 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 Jpi Healthcare Co, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260482?

K260482 is the FDA 510(k) for DRE Duo, submitted by Jpi Healthcare Co, Ltd.. FDA's decision date was Jun 15, 2026, under product code KPR (System, X-Ray, Stationary).

Who makes the DRE Duo?

Jpi Healthcare Co, Ltd., based in Seoul, is the applicant of record for K260482.

How long did the K260482 review take?

FDA received the submission on Feb 13, 2026 and issued its decision on Jun 15, 2026, 122 days later.

← All decisions in June 2026