WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

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 / February 2026 / K253221

510(k) cleared

Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)

Eieling Technology (Shenzhen) Limited · Feb 6, 2026 · K253221

FDA cleared the Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) from Eieling Technology (Shenzhen) Limited on Feb 6, 2026 under K253221, a traditional 510(k). The device falls under product code IYO, System, Imaging, Pulsed Echo, Ultrasonic, regulated at 21 CFR 892.1560 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Sep 29, 2025. The decision came 130 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 Eieling Technology (Shenzhen) Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253221?

K253221 is the FDA 510(k) for Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro), submitted by Eieling Technology (Shenzhen) Limited. FDA's decision date was Feb 6, 2026, under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic).

Who makes the Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)?

Eieling Technology (Shenzhen) Limited, based in Shenzhen, is the applicant of record for K253221.

How long did the K253221 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Feb 6, 2026, 130 days later.

← All decisions in February 2026