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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 / K252809

510(k) cleared

in2 Smart (in2S)

Virility Medical , Ltd. · Apr 6, 2026 · K252809

FDA cleared the in2 Smart (in2S) from Virility Medical , Ltd. on Apr 6, 2026 under K252809, a traditional 510(k). The device falls under product code QRC, Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation, regulated at 21 CFR 876.5026 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Sep 3, 2025. The decision came 215 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 Virility Medical , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252809?

K252809 is the FDA 510(k) for in2 Smart (in2S), submitted by Virility Medical , Ltd.. FDA's decision date was Apr 6, 2026, under product code QRC (Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation).

Who makes the in2 Smart (in2S)?

Virility Medical , Ltd., based in Hod Hasharon, is the applicant of record for K252809.

How long did the K252809 review take?

FDA received the submission on Sep 3, 2025 and issued its decision on Apr 6, 2026, 215 days later.

← All decisions in April 2026