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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 / K260178

510(k) cleared

Pelvic Muscle Trainer (KM510, KM516B)

Shenzhen Konmed Technology Co., Ltd. · Jun 18, 2026 · K260178

FDA cleared the Pelvic Muscle Trainer (KM510, KM516B) from Shenzhen Konmed Technology Co., Ltd. on Jun 18, 2026 under K260178, a traditional 510(k). The device falls under product code KPI, Stimulator, Electrical, Non-Implantable, For Incontinence, regulated at 21 CFR 876.5320 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jan 21, 2026. The decision came 148 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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

Questions & Answers

What did FDA clear under K260178?

K260178 is the FDA 510(k) for Pelvic Muscle Trainer (KM510, KM516B), submitted by Shenzhen Konmed Technology Co., Ltd.. FDA's decision date was Jun 18, 2026, under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence).

Who makes the Pelvic Muscle Trainer (KM510, KM516B)?

Shenzhen Konmed Technology Co., Ltd., based in Shenzhen, is the applicant of record for K260178.

How long did the K260178 review take?

FDA received the submission on Jan 21, 2026 and issued its decision on Jun 18, 2026, 148 days later.

← All decisions in June 2026