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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 / May 2026 / K254125

510(k) cleared

Electric Breast Pump (HL-3058 II Pro)

Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. · May 13, 2026 · K254125

FDA cleared the Electric Breast Pump (HL-3058 II Pro) from Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. on May 13, 2026 under K254125, 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 Dec 19, 2025. The decision came 145 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. has 2 other decisions in the tracker over the last 12 months: K252629 (Electric Breast Pump (HL-3058, F5112)), K252630 (Electric Breast Pump (HL-3060, F5113)).

Questions & Answers

What did FDA clear under K254125?

K254125 is the FDA 510(k) for Electric Breast Pump (HL-3058 II Pro), submitted by Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.. FDA's decision date was May 13, 2026, under product code HGX (Pump, Breast, Powered).

Who makes the Electric Breast Pump (HL-3058 II Pro)?

Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd., based in Shanghai, is the applicant of record for K254125.

How long did the K254125 review take?

FDA received the submission on Dec 19, 2025 and issued its decision on May 13, 2026, 145 days later.

← All decisions in May 2026

Sources