WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / October 2025 / K252629

510(k) cleared

Electric Breast Pump (HL-3058, F5112)

Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. · Oct 27, 2025 · K252629

FDA cleared the Electric Breast Pump (HL-3058, F5112) from Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. on Oct 27, 2025 under K252629, 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 Aug 20, 2025. The decision came 68 days later, inside the 90 FDA-day goal for a 510(k).

Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. has 2 other decisions in the tracker over the last 12 months: K254125 (Electric Breast Pump (HL-3058 II Pro)), K252630 (Electric Breast Pump (HL-3060, F5113)).

Questions & Answers

What did FDA clear under K252629?

K252629 is the FDA 510(k) for Electric Breast Pump (HL-3058, F5112), submitted by Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.. FDA's decision date was Oct 27, 2025, under product code HGX (Pump, Breast, Powered).

Who makes the Electric Breast Pump (HL-3058, F5112)?

Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd., based in Shanghai, is the applicant of record for K252629.

How long did the K252629 review take?

FDA received the submission on Aug 20, 2025 and issued its decision on Oct 27, 2025, 68 days later.

← All decisions in October 2025

Sources