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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 / February 2026 / K251992

510(k) cleared

ArmSure Fluoroscopic Positioning System

Savfe Co. , Ltd. · Feb 11, 2026 · K251992

FDA cleared the ArmSure Fluoroscopic Positioning System from Savfe Co. , Ltd. on Feb 11, 2026 under K251992, a traditional 510(k). The device falls under product code OWB, Interventional Fluoroscopic X-Ray System, regulated at 21 CFR 892.1650 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jun 27, 2025. The decision came 229 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 Savfe Co. , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251992?

K251992 is the FDA 510(k) for ArmSure Fluoroscopic Positioning System, submitted by Savfe Co. , Ltd.. FDA's decision date was Feb 11, 2026, under product code OWB (Interventional Fluoroscopic X-Ray System).

Who makes the ArmSure Fluoroscopic Positioning System?

Savfe Co. , Ltd., based in New Taipei City, is the applicant of record for K251992.

How long did the K251992 review take?

FDA received the submission on Jun 27, 2025 and issued its decision on Feb 11, 2026, 229 days later.

← All decisions in February 2026