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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 / March 2026 / K253029

510(k) cleared

RW-1

Mediott, Inc. · Mar 31, 2026 · K253029

FDA cleared the RW-1 from Mediott, Inc. on Mar 31, 2026 under K253029, a traditional 510(k). The device falls under product code LLZ, System, Image Processing, Radiological, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Sep 19, 2025. The decision came 193 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 Mediott, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253029?

K253029 is the FDA 510(k) for RW-1, submitted by Mediott, Inc.. FDA's decision date was Mar 31, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the RW-1?

Mediott, Inc., based in Shinjuku-Ku, is the applicant of record for K253029.

How long did the K253029 review take?

FDA received the submission on Sep 19, 2025 and issued its decision on Mar 31, 2026, 193 days later.

← All decisions in March 2026