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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 / K260864

510(k) cleared

Mother's Nature W1 Warming Wearable Breast Pump

Shenzhen TPH Technology Co., Ltd. · Jun 9, 2026 · K260864

FDA cleared the Mother's Nature W1 Warming Wearable Breast Pump from Shenzhen TPH Technology Co., Ltd. on Jun 9, 2026 under K260864, 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 17, 2026. The decision came 84 days later, inside the 90 FDA-day goal for a 510(k).

Shenzhen TPH Technology Co., Ltd. has 7 other decisions in the tracker over the last 12 months: K260259 (DiscreetDuo Flow Wearable Breast Pump (Model S3)), K261199 (Wearable Breast Pump (Model S32A)), K254244 (Wearable Breast Pump (Model S39)), K260033 (Wearable Breast Pump (Model S21A)).

Questions & Answers

What did FDA clear under K260864?

K260864 is the FDA 510(k) for Mother's Nature W1 Warming Wearable Breast Pump, submitted by Shenzhen TPH Technology Co., Ltd.. FDA's decision date was Jun 9, 2026, under product code HGX (Pump, Breast, Powered).

Who makes the Mother's Nature W1 Warming Wearable Breast Pump?

Shenzhen TPH Technology Co., Ltd., based in Shenzhen, is the applicant of record for K260864.

How long did the K260864 review take?

FDA received the submission on Mar 17, 2026 and issued its decision on Jun 9, 2026, 84 days later.

← All decisions in June 2026