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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 / K260956

510(k) cleared

Spectra Platinum Mini

Uzinmedicare Co., Ltd. · Jun 4, 2026 · K260956

FDA cleared the Spectra Platinum Mini from Uzinmedicare Co., Ltd. on Jun 4, 2026 under K260956, a traditional 510(k). The device falls under product code HGX, Pump, Breast, Powered, regulated at 21 CFR 884.5160 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Mar 23, 2026. The decision came 73 days later, inside the 90 FDA-day goal for a 510(k).

Uzinmedicare Co., Ltd. has 3 other decisions in the tracker over the last 12 months: K250208 (SPECTRA Wearable 2), K251423 (Spectra S1 Pro; Spectra S2 Pro), K251932 (Spectra Platinum).

Questions & Answers

What did FDA clear under K260956?

K260956 is the FDA 510(k) for Spectra Platinum Mini, submitted by Uzinmedicare Co., Ltd.. FDA's decision date was Jun 4, 2026, under product code HGX (Pump, Breast, Powered).

Who makes the Spectra Platinum Mini?

Uzinmedicare Co., Ltd., based in Gyeonggi-Do, is the applicant of record for K260956.

How long did the K260956 review take?

FDA received the submission on Mar 23, 2026 and issued its decision on Jun 4, 2026, 73 days later.

← All decisions in June 2026

Sources