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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 / K252748

510(k) cleared

Pelvic Floor Exerciser (PF01)

Hunan Accurate Bio-Medical Technology Co., Ltd. · Apr 27, 2026 · K252748

FDA cleared the Pelvic Floor Exerciser (PF01) from Hunan Accurate Bio-Medical Technology Co., Ltd. on Apr 27, 2026 under K252748, a traditional 510(k). The device falls under product code HIR, Perineometer, regulated at 21 CFR 884.1425 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Aug 29, 2025. The decision came 241 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: K252601 (Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L)).

Questions & Answers

What did FDA clear under K252748?

K252748 is the FDA 510(k) for Pelvic Floor Exerciser (PF01), submitted by Hunan Accurate Bio-Medical Technology Co., Ltd.. FDA's decision date was Apr 27, 2026, under product code HIR (Perineometer).

Who makes the Pelvic Floor Exerciser (PF01)?

Hunan Accurate Bio-Medical Technology Co., Ltd., based in Changsha, is the applicant of record for K252748.

How long did the K252748 review take?

FDA received the submission on Aug 29, 2025 and issued its decision on Apr 27, 2026, 241 days later.

← All decisions in April 2026

Sources