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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 / September 2025 / K250216

510(k) cleared

OsteoProbe (OP-100)

Active Life Scientific, Inc. · Sep 11, 2025 · K250216

FDA cleared the OsteoProbe (OP-100) from Active Life Scientific, Inc. on Sep 11, 2025 under K250216, a traditional 510(k). The device falls under product code QGQ, Bone Indentation Device, regulated at 21 CFR 888.1600 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jan 24, 2025. The decision came 230 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 Active Life Scientific, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250216?

K250216 is the FDA 510(k) for OsteoProbe (OP-100), submitted by Active Life Scientific, Inc.. FDA's decision date was Sep 11, 2025, under product code QGQ (Bone Indentation Device).

Who makes the OsteoProbe (OP-100)?

Active Life Scientific, Inc., based in Santa Barbara, CA, is the applicant of record for K250216.

How long did the K250216 review take?

FDA received the submission on Jan 24, 2025 and issued its decision on Sep 11, 2025, 230 days later.

← All decisions in September 2025