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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 / K242817

510(k) cleared

Jason membrane

Botiss Biomaterials GmbH · Dec 12, 2025 · K242817

FDA cleared the Jason membrane from Botiss Biomaterials GmbH on Dec 12, 2025 under K242817, 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 Sep 18, 2024. The decision came 450 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 Botiss Biomaterials GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K242817?

K242817 is the FDA 510(k) for Jason membrane, submitted by Botiss Biomaterials GmbH. FDA's decision date was Dec 12, 2025, under product code NPL (Barrier, Animal Source, Intraoral).

Who makes the Jason membrane?

Botiss Biomaterials GmbH, based in Zossen, is the applicant of record for K242817.

How long did the K242817 review take?

FDA received the submission on Sep 18, 2024 and issued its decision on Dec 12, 2025, 450 days later.

← All decisions in December 2025