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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 / December 2025 / K251893

510(k) cleared

SKAN C PULSAR

Skanray Technologies Limited · Dec 16, 2025 · K251893

FDA cleared the SKAN C PULSAR from Skanray Technologies Limited on Dec 16, 2025 under K251893, 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 20, 2025. The decision came 179 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 Skanray Technologies Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251893?

K251893 is the FDA 510(k) for SKAN C PULSAR, submitted by Skanray Technologies Limited. FDA's decision date was Dec 16, 2025, under product code OWB (Interventional Fluoroscopic X-Ray System).

Who makes the SKAN C PULSAR?

Skanray Technologies Limited, based in Mysore, is the applicant of record for K251893.

How long did the K251893 review take?

FDA received the submission on Jun 20, 2025 and issued its decision on Dec 16, 2025, 179 days later.

← All decisions in December 2025