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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 / September 2025 / K250659

510(k) cleared

LoFric Origo

Wellspect AB · Sep 26, 2025 · K250659

FDA cleared the LoFric Origo from Wellspect AB on Sep 26, 2025 under K250659, a traditional 510(k). The device falls under product code EZD, Catheter, Straight, regulated at 21 CFR 876.5130 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Mar 5, 2025. The decision came 205 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Wellspect AB has 2 other decisions in the tracker over the last 12 months: K261658 (LoFric Origo Pro Coudé), K260999 (LoFric Elle Pro).

Questions & Answers

What did FDA clear under K250659?

K250659 is the FDA 510(k) for LoFric Origo, submitted by Wellspect AB. FDA's decision date was Sep 26, 2025, under product code EZD (Catheter, Straight).

Who makes the LoFric Origo?

Wellspect AB, based in Mölndal, is the applicant of record for K250659.

How long did the K250659 review take?

FDA received the submission on Mar 5, 2025 and issued its decision on Sep 26, 2025, 205 days later.

← All decisions in September 2025

Sources