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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 / K243438

510(k) cleared

MEMO Patch M (MPT-E08R-UNC01)

Huinno Co., Ltd. · Dec 5, 2025 · K243438

FDA cleared the MEMO Patch M (MPT-E08R-UNC01) from Huinno Co., Ltd. on Dec 5, 2025 under K243438, a traditional 510(k). The device falls under product code DXH, Transmitters And Receivers, Electrocardiograph, Telephone, regulated at 21 CFR 870.2920 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Nov 6, 2024. The decision came 394 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 Huinno Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K243438?

K243438 is the FDA 510(k) for MEMO Patch M (MPT-E08R-UNC01), submitted by Huinno Co., Ltd.. FDA's decision date was Dec 5, 2025, under product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone).

Who makes the MEMO Patch M (MPT-E08R-UNC01)?

Huinno Co., Ltd., based in Seoul, is the applicant of record for K243438.

How long did the K243438 review take?

FDA received the submission on Nov 6, 2024 and issued its decision on Dec 5, 2025, 394 days later.

← All decisions in December 2025