WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

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 / December 2025 / K250795

510(k) cleared

PUREVUE FMS

W.O.M. World of Medicine GmbH · Dec 5, 2025 · K250795

FDA cleared the PUREVUE FMS from W.O.M. World of Medicine GmbH on Dec 5, 2025 under K250795, a traditional 510(k). The device falls under product code HRX, Arthroscope, regulated at 21 CFR 888.1100 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Mar 14, 2025. The decision came 266 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 W.O.M. World of Medicine GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250795?

K250795 is the FDA 510(k) for PUREVUE FMS, submitted by W.O.M. World of Medicine GmbH. FDA's decision date was Dec 5, 2025, under product code HRX (Arthroscope).

Who makes the PUREVUE FMS?

W.O.M. World of Medicine GmbH, based in Berlin, is the applicant of record for K250795.

How long did the K250795 review take?

FDA received the submission on Mar 14, 2025 and issued its decision on Dec 5, 2025, 266 days later.

← All decisions in December 2025