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Home » TSC Life wins FDA clearance for pediatric use of Fluido system

TSC Life wins FDA clearance for pediatric use of Fluido system

February 4, 2026 By Sean Whooley

Fluido Compact TSC Life
The Fluido compact fluid warming system. [Image from TSC Life]
TSC Life announced that it received FDA clearance for its Fluido Compact fluid warming system for pediatric use.

Pediatric clearance allows TSC Life to market the system to hospitals specifically for this patient population in the U.S. and Canada.

Fluido Compact accompanies patients throughout the entire care journey, from the emergency department to the operating room and into recovery. TSC Life describes it as uniquely suited for hospitals and clinics looking for low-flow blood and fluid warmers for pediatric and adult uses.

The system offers easy setup, operation and maintenance, plus low priming volume, portability within the hospital and normothermic flow rates. Those rates start as low as 5 mL/min.

Fluido Compact’s clearance covers pediatric patients and newborns weighing as little as 7.7 pounds (3.5 kilograms) and above.

“The FDA’s clearance is a strong recognition of the safety and benefits of this fluid warming system to this vulnerable pediatric population, which are the most critical patients at risk for inadvertent hypothermia during surgery,” said Chris Duffie, U.S. commercial VP. “We are thrilled to bring Fluido Compact to clients in the U.S. and Canada. It is a high-quality and reliable system that has been on the market in Europe and many parts of the world for more than 10 years. The Fluido® Compact is a trusted and proven solution, with a global installation base in excess of 10,000 units.”

Filed Under: 510(k), Blood Management, Food & Drug Administration (FDA), Pediatrics, Regulatory/Compliance Tagged With: TSC Life

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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