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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 / November 2025 / K251932

510(k) cleared

Spectra Platinum

Uzinmedicare Co., Ltd. · Nov 25, 2025 · K251932

FDA cleared the Spectra Platinum from Uzinmedicare Co., Ltd. on Nov 25, 2025 under K251932, 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 Jun 24, 2025. The decision came 154 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Uzinmedicare Co., Ltd. has 3 other decisions in the tracker over the last 12 months: K260956 (Spectra Platinum Mini), K250208 (SPECTRA Wearable 2), K251423 (Spectra S1 Pro; Spectra S2 Pro).

Questions & Answers

What did FDA clear under K251932?

K251932 is the FDA 510(k) for Spectra Platinum, submitted by Uzinmedicare Co., Ltd.. FDA's decision date was Nov 25, 2025, under product code HGX (Pump, Breast, Powered).

Who makes the Spectra Platinum?

Uzinmedicare Co., Ltd., based in Gyeonggi-Do, is the applicant of record for K251932.

How long did the K251932 review take?

FDA received the submission on Jun 24, 2025 and issued its decision on Nov 25, 2025, 154 days later.

← All decisions in November 2025

Sources