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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 / K250208

510(k) cleared

SPECTRA Wearable 2

Uzinmedicare Co., Ltd. · Apr 6, 2026 · K250208

FDA cleared the SPECTRA Wearable 2 from Uzinmedicare Co., Ltd. on Apr 6, 2026 under K250208, 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 Jan 24, 2025. The decision came 437 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), K251423 (Spectra S1 Pro; Spectra S2 Pro), K251932 (Spectra Platinum).

Questions & Answers

What did FDA clear under K250208?

K250208 is the FDA 510(k) for SPECTRA Wearable 2, submitted by Uzinmedicare Co., Ltd.. FDA's decision date was Apr 6, 2026, under product code HGX (Pump, Breast, Powered).

Who makes the SPECTRA Wearable 2?

Uzinmedicare Co., Ltd., based in Gyeonggi-Do, is the applicant of record for K250208.

How long did the K250208 review take?

FDA received the submission on Jan 24, 2025 and issued its decision on Apr 6, 2026, 437 days later.

← All decisions in April 2026

Sources