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THE TAPE

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 / K252601

510(k) cleared

Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L)

Hunan Accurate Bio-Medical Technology Co., Ltd. · May 14, 2026 · K252601

FDA cleared the Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L) from Hunan Accurate Bio-Medical Technology Co., Ltd. on May 14, 2026 under K252601, 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 Aug 18, 2025. The decision came 269 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Hunan Accurate Bio-Medical Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K252748 (Pelvic Floor Exerciser (PF01)).

Questions & Answers

What did FDA clear under K252601?

K252601 is the FDA 510(k) for Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L), submitted by Hunan Accurate Bio-Medical Technology Co., Ltd.. FDA's decision date was May 14, 2026, under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence).

Who makes the Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L)?

Hunan Accurate Bio-Medical Technology Co., Ltd., based in Changsha, is the applicant of record for K252601.

How long did the K252601 review take?

FDA received the submission on Aug 18, 2025 and issued its decision on May 14, 2026, 269 days later.

← All decisions in May 2026

Sources