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THE TAPE

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 / July 2026 / K251908

510(k) cleared

Emanate Tray

Emanate Biomedical · Jul 29, 2026 · K251908

FDA cleared the Emanate Tray from Emanate Biomedical on Jul 29, 2026 under K251908, a traditional 510(k). The device falls under product code OLR, Oral Wound Dressing as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Jun 20, 2025. The decision came 404 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 Emanate Biomedical in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251908?

K251908 is the FDA 510(k) for Emanate Tray, submitted by Emanate Biomedical. FDA's decision date was Jul 29, 2026, under product code OLR (Oral Wound Dressing).

Who makes the Emanate Tray?

Emanate Biomedical, based in New York, NY, is the applicant of record for K251908.

How long did the K251908 review take?

FDA received the submission on Jun 20, 2025 and issued its decision on Jul 29, 2026, 404 days later.

← All decisions in July 2026