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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 / K252950

510(k) cleared

Paradigm System

Proprio, Inc. · Dec 15, 2025 · K252950

FDA cleared the Paradigm System from Proprio, Inc. on Dec 15, 2025 under K252950, a traditional 510(k). The device falls under product code OLO, Orthopedic Stereotaxic Instrument, regulated at 21 CFR 882.4560 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Sep 16, 2025. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Proprio, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252950?

K252950 is the FDA 510(k) for Paradigm System, submitted by Proprio, Inc.. FDA's decision date was Dec 15, 2025, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the Paradigm System?

Proprio, Inc., based in Seattle, WA, is the applicant of record for K252950.

How long did the K252950 review take?

FDA received the submission on Sep 16, 2025 and issued its decision on Dec 15, 2025, 90 days later.

← All decisions in December 2025