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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 / K243449

510(k) cleared

INFINITT DPS

Infinitt Healthcare Co., Ltd. · Dec 9, 2025 · K243449

FDA cleared the INFINITT DPS from Infinitt Healthcare Co., Ltd. on Dec 9, 2025 under K243449, a traditional 510(k). The device falls under product code QKQ, Digital Pathology Image Viewing And Management Software, regulated at 21 CFR 864.3700 as a Class 2 device. The review panel was Pathology.

FDA logged the submission as received on Nov 7, 2024. The decision came 397 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 Infinitt Healthcare Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K243449?

K243449 is the FDA 510(k) for INFINITT DPS, submitted by Infinitt Healthcare Co., Ltd.. FDA's decision date was Dec 9, 2025, under product code QKQ (Digital Pathology Image Viewing And Management Software).

Who makes the INFINITT DPS?

Infinitt Healthcare Co., Ltd., based in Seoul, is the applicant of record for K243449.

How long did the K243449 review take?

FDA received the submission on Nov 7, 2024 and issued its decision on Dec 9, 2025, 397 days later.

← All decisions in December 2025