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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 / K251423

510(k) cleared

Spectra S1 Pro; Spectra S2 Pro

Uzinmedicare Co., Ltd. · Feb 6, 2026 · K251423

FDA cleared the Spectra S1 Pro; Spectra S2 Pro from Uzinmedicare Co., Ltd. on Feb 6, 2026 under K251423, 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 May 8, 2025. The decision came 274 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), K251932 (Spectra Platinum).

Questions & Answers

What did FDA clear under K251423?

K251423 is the FDA 510(k) for Spectra S1 Pro; Spectra S2 Pro, submitted by Uzinmedicare Co., Ltd.. FDA's decision date was Feb 6, 2026, under product code HGX (Pump, Breast, Powered).

Who makes the Spectra S1 Pro; Spectra S2 Pro?

Uzinmedicare Co., Ltd., based in Gyeonggi-Do, is the applicant of record for K251423.

How long did the K251423 review take?

FDA received the submission on May 8, 2025 and issued its decision on Feb 6, 2026, 274 days later.

← All decisions in February 2026

Sources