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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 / April 2026 / K260239

510(k) cleared

Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862)

Jiangxi AOV Maternity & Baby Products Co., Ltd. · Apr 22, 2026 · K260239

FDA cleared the Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862) from Jiangxi AOV Maternity & Baby Products Co., Ltd. on Apr 22, 2026 under K260239, 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 26, 2026. The decision came 86 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Jiangxi AOV Maternity & Baby Products Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260239?

K260239 is the FDA 510(k) for Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862), submitted by Jiangxi AOV Maternity & Baby Products Co., Ltd.. FDA's decision date was Apr 22, 2026, under product code HGX (Pump, Breast, Powered).

Who makes the Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862)?

Jiangxi AOV Maternity & Baby Products Co., Ltd., based in Guixi, is the applicant of record for K260239.

How long did the K260239 review take?

FDA received the submission on Jan 26, 2026 and issued its decision on Apr 22, 2026, 86 days later.

← All decisions in April 2026