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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 / July 2026 / K260259

510(k) cleared

DiscreetDuo Flow Wearable Breast Pump (Model S3)

Shenzhen TPH Technology Co., Ltd. · Jul 24, 2026 · K260259

FDA cleared the DiscreetDuo Flow Wearable Breast Pump (Model S3) from Shenzhen TPH Technology Co., Ltd. on Jul 24, 2026 under K260259, 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 Jan 28, 2026. The decision came 177 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: K261199 (Wearable Breast Pump (Model S32A)), K260864 (Mother's Nature W1 Warming Wearable Breast Pump), K254244 (Wearable Breast Pump (Model S39)), K260033 (Wearable Breast Pump (Model S21A)).

Questions & Answers

What did FDA clear under K260259?

K260259 is the FDA 510(k) for DiscreetDuo Flow Wearable Breast Pump (Model S3), submitted by Shenzhen TPH Technology Co., Ltd.. FDA's decision date was Jul 24, 2026, under product code HGX (Pump, Breast, Powered).

Who makes the DiscreetDuo Flow Wearable Breast Pump (Model S3)?

Shenzhen TPH Technology Co., Ltd., based in Shenzhen, is the applicant of record for K260259.

How long did the K260259 review take?

FDA received the submission on Jan 28, 2026 and issued its decision on Jul 24, 2026, 177 days later.

← All decisions in July 2026