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THE TAPE

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 / March 2026 / K252421

510(k) cleared

JLK-NCCT

JLK, Inc. · Mar 24, 2026 · K252421

FDA cleared the JLK-NCCT from JLK, Inc. on Mar 24, 2026 under K252421, a traditional 510(k). The device falls under product code QAS, Radiological Computer-Assisted Triage And Notification Software, regulated at 21 CFR 892.2080 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Aug 1, 2025. The decision came 235 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 JLK, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252421?

K252421 is the FDA 510(k) for JLK-NCCT, submitted by JLK, Inc.. FDA's decision date was Mar 24, 2026, under product code QAS (Radiological Computer-Assisted Triage And Notification Software).

Who makes the JLK-NCCT?

JLK, Inc., based in Seoul, is the applicant of record for K252421.

How long did the K252421 review take?

FDA received the submission on Aug 1, 2025 and issued its decision on Mar 24, 2026, 235 days later.

← All decisions in March 2026