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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 / K250512

510(k) cleared

Augmented Gingival Matrix

Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. · Dec 5, 2025 · K250512

FDA cleared the Augmented Gingival Matrix from Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. on Dec 5, 2025 under K250512, a traditional 510(k). The device falls under product code NPL, Barrier, Animal Source, Intraoral, regulated at 21 CFR 872.3930 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Feb 21, 2025. The decision came 287 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 Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250512?

K250512 is the FDA 510(k) for Augmented Gingival Matrix, submitted by Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.. FDA's decision date was Dec 5, 2025, under product code NPL (Barrier, Animal Source, Intraoral).

Who makes the Augmented Gingival Matrix?

Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd., based in Suzhou, is the applicant of record for K250512.

How long did the K250512 review take?

FDA received the submission on Feb 21, 2025 and issued its decision on Dec 5, 2025, 287 days later.

← All decisions in December 2025