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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 / K251083

510(k) cleared

Compact II

Enraf-Nonius, B.V. · Sep 12, 2025 · K251083

FDA cleared the Compact II from Enraf-Nonius, B.V. on Sep 12, 2025 under K251083, a traditional 510(k). The device falls under product code IPF, Stimulator, Muscle, Powered, regulated at 21 CFR 890.5850 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Apr 9, 2025. The decision came 156 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 Enraf-Nonius, B.V. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251083?

K251083 is the FDA 510(k) for Compact II, submitted by Enraf-Nonius, B.V.. FDA's decision date was Sep 12, 2025, under product code IPF (Stimulator, Muscle, Powered).

Who makes the Compact II?

Enraf-Nonius, B.V., based in Rotterdam, is the applicant of record for K251083.

How long did the K251083 review take?

FDA received the submission on Apr 9, 2025 and issued its decision on Sep 12, 2025, 156 days later.

← All decisions in September 2025