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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 / April 2026 / K253573

510(k) cleared

ASTar BC G- Kit

Q-Linea AB · Apr 15, 2026 · K253573

FDA cleared the ASTar BC G- Kit from Q-Linea AB on Apr 15, 2026 under K253573, a traditional 510(k). The device falls under product code SAN, Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples, regulated at 21 CFR 866.1650 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Nov 17, 2025. The decision came 149 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 Q-Linea AB in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253573?

K253573 is the FDA 510(k) for ASTar BC G- Kit, submitted by Q-Linea AB. FDA's decision date was Apr 15, 2026, under product code SAN (Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples).

Who makes the ASTar BC G- Kit?

Q-Linea AB, based in Uppsala, is the applicant of record for K253573.

How long did the K253573 review take?

FDA received the submission on Nov 17, 2025 and issued its decision on Apr 15, 2026, 149 days later.

← All decisions in April 2026