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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 / K254244

510(k) cleared

Wearable Breast Pump (Model S39)

Shenzhen TPH Technology Co., Ltd. · May 21, 2026 · K254244

FDA cleared the Wearable Breast Pump (Model S39) from Shenzhen TPH Technology Co., Ltd. on May 21, 2026 under K254244, 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 29, 2025. The decision came 143 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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)), K260864 (Mother's Nature W1 Warming Wearable Breast Pump), K260033 (Wearable Breast Pump (Model S21A)).

Questions & Answers

What did FDA clear under K254244?

K254244 is the FDA 510(k) for Wearable Breast Pump (Model S39), submitted by Shenzhen TPH Technology Co., Ltd.. FDA's decision date was May 21, 2026, under product code HGX (Pump, Breast, Powered).

Who makes the Wearable Breast Pump (Model S39)?

Shenzhen TPH Technology Co., Ltd., based in Shenzhen, is the applicant of record for K254244.

How long did the K254244 review take?

FDA received the submission on Dec 29, 2025 and issued its decision on May 21, 2026, 143 days later.

← All decisions in May 2026