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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 / April 2026 / K252241

510(k) cleared

Pressio 3 Multi-parameter Neuromonitoring System

Sophysa · Apr 10, 2026 · K252241

FDA cleared the Pressio 3 Multi-parameter Neuromonitoring System from Sophysa on Apr 10, 2026 under K252241, a traditional 510(k). The device falls under product code GWM, Device, Monitoring, Intracranial Pressure, regulated at 21 CFR 882.1620 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Jul 17, 2025. The decision came 267 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Sophysa has one other decision in the tracker over the last 12 months: K250636 (Sophy Mini Monopressure Valve (SM1)).

Questions & Answers

What did FDA clear under K252241?

K252241 is the FDA 510(k) for Pressio 3 Multi-parameter Neuromonitoring System, submitted by Sophysa. FDA's decision date was Apr 10, 2026, under product code GWM (Device, Monitoring, Intracranial Pressure).

Who makes the Pressio 3 Multi-parameter Neuromonitoring System?

Sophysa, based in Orsay, is the applicant of record for K252241.

How long did the K252241 review take?

FDA received the submission on Jul 17, 2025 and issued its decision on Apr 10, 2026, 267 days later.

← All decisions in April 2026

Sources