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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 / February 2026 / K254271

510(k) cleared

CAPRI

ORO Co., Ltd. · Feb 26, 2026 · K254271

FDA cleared the CAPRI from ORO Co., Ltd. on Feb 26, 2026 under K254271, a traditional 510(k). The device falls under product code GEX, Powered Laser Surgical Instrument, regulated at 21 CFR 878.4810 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Dec 30, 2025. The decision came 58 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for ORO Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254271?

K254271 is the FDA 510(k) for CAPRI, submitted by ORO Co., Ltd.. FDA's decision date was Feb 26, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the CAPRI?

ORO Co., Ltd., based in Gimpo-Si, is the applicant of record for K254271.

How long did the K254271 review take?

FDA received the submission on Dec 30, 2025 and issued its decision on Feb 26, 2026, 58 days later.

← All decisions in February 2026