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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 / March 2026 / K251999

510(k) cleared

Promogran Prisma Collagen Matrix with ORC and Silver

Solventum Germany GmbH · Mar 13, 2026 · K251999

FDA cleared the Promogran Prisma Collagen Matrix with ORC and Silver from Solventum Germany GmbH on Mar 13, 2026 under K251999, a traditional 510(k). The device falls under product code FRO, Dressing, Wound, Drug as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Jun 27, 2025. The decision came 259 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 Solventum Germany GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251999?

K251999 is the FDA 510(k) for Promogran Prisma Collagen Matrix with ORC and Silver, submitted by Solventum Germany GmbH. FDA's decision date was Mar 13, 2026, under product code FRO (Dressing, Wound, Drug).

Who makes the Promogran Prisma Collagen Matrix with ORC and Silver?

Solventum Germany GmbH, based in Kamen, is the applicant of record for K251999.

How long did the K251999 review take?

FDA received the submission on Jun 27, 2025 and issued its decision on Mar 13, 2026, 259 days later.

← All decisions in March 2026