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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 / October 2025 / K252851

510(k) cleared

deepLive (OSP12 + DMS)

Damae Medical · Oct 7, 2025 · K252851

FDA cleared the deepLive (OSP12 + DMS) from Damae Medical on Oct 7, 2025 under K252851, a special 510(k). The device falls under product code NQQ, System, Imaging, Optical Coherence Tomography (Oct), regulated at 21 CFR 892.1560 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Sep 8, 2025. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Damae Medical in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252851?

K252851 is the FDA 510(k) for deepLive (OSP12 + DMS), submitted by Damae Medical. FDA's decision date was Oct 7, 2025, under product code NQQ (System, Imaging, Optical Coherence Tomography (Oct)).

Who makes the deepLive (OSP12 + DMS)?

Damae Medical, based in Paris, is the applicant of record for K252851.

How long did the K252851 review take?

FDA received the submission on Sep 8, 2025 and issued its decision on Oct 7, 2025, 29 days later.

← All decisions in October 2025