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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 / K252636

510(k) cleared

Fluido Compact System

The Surgical Company International B.V. · Nov 18, 2025 · K252636

FDA cleared the Fluido Compact System from The Surgical Company International B.V. on Nov 18, 2025 under K252636, a traditional 510(k). The device falls under product code LGZ, Warmer, Thermal, Infusion Fluid, regulated at 21 CFR 880.5725 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Aug 20, 2025. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

The Surgical Company International B.V. has one other decision in the tracker over the last 12 months: K261437 (Mistral-Air® Warming System).

Questions & Answers

What did FDA clear under K252636?

K252636 is the FDA 510(k) for Fluido Compact System, submitted by The Surgical Company International B.V.. FDA's decision date was Nov 18, 2025, under product code LGZ (Warmer, Thermal, Infusion Fluid).

Who makes the Fluido Compact System?

The Surgical Company International B.V., based in Amsterdam, is the applicant of record for K252636.

How long did the K252636 review take?

FDA received the submission on Aug 20, 2025 and issued its decision on Nov 18, 2025, 90 days later.

← All decisions in November 2025

Sources