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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 / K251268

510(k) cleared

Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)

Edan Instruments, Inc. · Dec 23, 2025 · K251268

FDA cleared the Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) from Edan Instruments, Inc. on Dec 23, 2025 under K251268, a traditional 510(k). The device falls under product code IYN, System, Imaging, Pulsed Doppler, Ultrasonic, regulated at 21 CFR 892.1550 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Apr 24, 2025. The decision came 243 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Edan Instruments, Inc. has 3 other decisions in the tracker over the last 12 months: K251508 (Telemetry Monitor (iT30, iT50)), K252463 (SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)), K251591 (Holter ECG and ABP system (HolterABP)).

Questions & Answers

What did FDA clear under K251268?

K251268 is the FDA 510(k) for Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP), submitted by Edan Instruments, Inc.. FDA's decision date was Dec 23, 2025, under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

Who makes the Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)?

Edan Instruments, Inc., based in Shenzhen, is the applicant of record for K251268.

How long did the K251268 review take?

FDA received the submission on Apr 24, 2025 and issued its decision on Dec 23, 2025, 243 days later.

← All decisions in December 2025

Sources