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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 / October 2025 / K250696

510(k) cleared

AccuCheck

Manteia Technologies Co., Ltd. · Oct 24, 2025 · K250696

FDA cleared the AccuCheck from Manteia Technologies Co., Ltd. on Oct 24, 2025 under K250696, a traditional 510(k). The device falls under product code IYE, Accelerator, Linear, Medical, regulated at 21 CFR 892.5050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Mar 7, 2025. The decision came 231 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Manteia Technologies Co., Ltd. has 2 other decisions in the tracker over the last 12 months: K251351 (AccuContour 4.0), K250780 (ARTAssistant).

Questions & Answers

What did FDA clear under K250696?

K250696 is the FDA 510(k) for AccuCheck, submitted by Manteia Technologies Co., Ltd.. FDA's decision date was Oct 24, 2025, under product code IYE (Accelerator, Linear, Medical).

Who makes the AccuCheck?

Manteia Technologies Co., Ltd., based in Xiamen, is the applicant of record for K250696.

How long did the K250696 review take?

FDA received the submission on Mar 7, 2025 and issued its decision on Oct 24, 2025, 231 days later.

← All decisions in October 2025

Sources