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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 / November 2025 / K250636

510(k) cleared

Sophy Mini Monopressure Valve (SM1)

Sophysa · Nov 28, 2025 · K250636

FDA cleared the Sophy Mini Monopressure Valve (SM1) from Sophysa on Nov 28, 2025 under K250636, a traditional 510(k). The device falls under product code JXG, Shunt, Central Nervous System And Components, regulated at 21 CFR 882.5550 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Mar 3, 2025. The decision came 270 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: K252241 (Pressio 3 Multi-parameter Neuromonitoring System).

Questions & Answers

What did FDA clear under K250636?

K250636 is the FDA 510(k) for Sophy Mini Monopressure Valve (SM1), submitted by Sophysa. FDA's decision date was Nov 28, 2025, under product code JXG (Shunt, Central Nervous System And Components).

Who makes the Sophy Mini Monopressure Valve (SM1)?

Sophysa, based in Orsay, is the applicant of record for K250636.

How long did the K250636 review take?

FDA received the submission on Mar 3, 2025 and issued its decision on Nov 28, 2025, 270 days later.

← All decisions in November 2025

Sources