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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 / January 2026 / K252749

510(k) cleared

Medconn 8K Glycated Hemoglobin Test System

Shanghai Medconn Medical Technology Co., Ltd. · Jan 6, 2026 · K252749

FDA cleared the Medconn 8K Glycated Hemoglobin Test System from Shanghai Medconn Medical Technology Co., Ltd. on Jan 6, 2026 under K252749, a traditional 510(k). The device falls under product code PDJ, Hemoglobin A1c Test System, regulated at 21 CFR 862.1373 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Aug 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 Shanghai Medconn Medical Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252749?

K252749 is the FDA 510(k) for Medconn 8K Glycated Hemoglobin Test System, submitted by Shanghai Medconn Medical Technology Co., Ltd.. FDA's decision date was Jan 6, 2026, under product code PDJ (Hemoglobin A1c Test System).

Who makes the Medconn 8K Glycated Hemoglobin Test System?

Shanghai Medconn Medical Technology Co., Ltd., based in Shanghai, is the applicant of record for K252749.

How long did the K252749 review take?

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

← All decisions in January 2026