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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 / December 2025 / K252391

510(k) cleared

Revi System

Bluewind Medical , Ltd. · Dec 12, 2025 · K252391

FDA cleared the Revi System from Bluewind Medical , Ltd. on Dec 12, 2025 under K252391, a traditional 510(k). The device falls under product code QXM, Implanted Tibial Electrical Urinary Continence Device, regulated at 21 CFR 876.5305 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jul 31, 2025. The decision came 134 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Bluewind Medical , Ltd. has one other decision in the tracker over the last 12 months: K253651 (Revi System).

Questions & Answers

What did FDA clear under K252391?

K252391 is the FDA 510(k) for Revi System, submitted by Bluewind Medical , Ltd.. FDA's decision date was Dec 12, 2025, under product code QXM (Implanted Tibial Electrical Urinary Continence Device).

Who makes the Revi System?

Bluewind Medical , Ltd., based in Herzliya, is the applicant of record for K252391.

How long did the K252391 review take?

FDA received the submission on Jul 31, 2025 and issued its decision on Dec 12, 2025, 134 days later.

← All decisions in December 2025

Sources