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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 / June 2026 / K261025

510(k) cleared

Wearable breast pump (QY-101, QY-102, QY-108)

Shenzhen Qinyi Electronic Technology Co., Ltd. · Jun 25, 2026 · K261025

FDA cleared the Wearable breast pump (QY-101, QY-102, QY-108) from Shenzhen Qinyi Electronic Technology Co., Ltd. on Jun 25, 2026 under K261025, 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 Mar 30, 2026. The decision came 87 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Shenzhen Qinyi Electronic Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261025?

K261025 is the FDA 510(k) for Wearable breast pump (QY-101, QY-102, QY-108), submitted by Shenzhen Qinyi Electronic Technology Co., Ltd.. FDA's decision date was Jun 25, 2026, under product code HGX (Pump, Breast, Powered).

Who makes the Wearable breast pump (QY-101, QY-102, QY-108)?

Shenzhen Qinyi Electronic Technology Co., Ltd., based in Shenzhen, is the applicant of record for K261025.

How long did the K261025 review take?

FDA received the submission on Mar 30, 2026 and issued its decision on Jun 25, 2026, 87 days later.

← All decisions in June 2026