TSC Life receives FDA 510(K) clearance for Fluido® Airguard System, a moderate to high flow blood and IV fluid warming solution for the prevention of hypothermia
FOR IMMEDIATE RELEASE
September 22, 2025
Contact: Dave Rawlings
For more information, contact customer service at (765) 205-6030, cs.us@tsc-life.com
www.tsc-life.com
Denver, CO — TSC Life announces FDA clearance of its moderate to high flow blood and fluid warmer, Fluido® AirGuard System, in the U.S. “We are thrilled to introduce this latest technology into the U.S. market. This high flow blood and fluid warming system combines high performance with ease of use and affordability,” said Chris Duffie, Commercial VP for the U.S.
In emergency care, surgery, ICU, labor and delivery, and severe trauma cases, the quick administration of warm IV fluids or blood products is crucial. Two-thirds of trauma patients are already suffering from mild hypothermia by the time they enter the emergency room. Just one unit of refrigerated blood or one liter of crystalloid at room temperature can reduce mean body temperature by 0.45° F.
The Fluido® AirGuard System combines rapid infusion with enhanced patient safety features for expedited care of these patients, protecting them during high flow blood and IV-fluid infusions. One such risk is outgassing—the release of dissolved gasses such as air when fluids are warmed. Outgassing can form bubbles that enter the bloodstream and may block blood flow, leading to serious complications such as stroke, heart attack, or even death. Fluido™ AirGuard System features automatic air detection and IV-line clamping to prevent air bubbles from entering the bloodstream.
Fluido® AirGuard delivers flow rates up to 800 mL/min (48 L/hr) and the removable warming cassette can move with the patient throughout their clinical journey. The system is pressurized in under 20 seconds and equipped with streamlined controls for safe, reliable care. Its proven compliance with current safety standards promotes patient safety without compromise. “Fluido® AirGuard is a best-in-class combination of clinical utility, patient safety, and cost-efficiency,” added Duffie.
In early 2025, TSC Life transitioned from relying on Stryker to distribute its Mistral-Air® portfolio to building its own direct commercial team in the U.S. market. Paraic Curtis, CEO of TSC Life, commented, “Moving to a direct commercial team in the U.S. was essential for our growth. This shift has accelerated company expansion, strengthened customer relationships, improved U.S. customer care, and opened the door for new product launches such as the Fluido® AirGuard System to the U.S. market.”
About TSC Life
TSC Life is a global medtech company based in the Netherlands with more than 30 years of experience in developing, manufacturing, and delivering healthcare solutions to hospitals and care facilities worldwide. The company is redefining healthcare with high-performance devices for temperature management and endoscopy, including Mistral-Air® forced air warming systems, Fluido® blood and fluid warming systems, and Broncoflex™ single-use bronchoscopes—each engineered to be brilliantly simple while ensuring efficient, high-quality patient care that supports evidence-based outcomes. The U.S. launch of the Fluido® AirGuard System highlights TSC Life’s commitment to creating solutions that are intuitive and fuss-free, so healthcare providers can focus less on devices and more on their patients.
