FDA Class I designation is granted to medical devices with an established safety profile and represents the foundational regulatory requirement for lawful sale and distribution of medical devices in the United States.
The Ventubation System has also been nominated for EMS World EXPO’s Innovation Award as one of the year’s most pioneering products. Determined by an independent panel of judges from the EMS World Editorial Advisory Board, which conducts one-on-one demos with finalists during the annual EMS Expo (September 28-October 2), EMS EXPO Innovation Award winners will be announced this fall.
Ventubation Systems has pioneered a new generation of airway management technologies designed to achieve safer, faster, and more reliable airway control to reduce intubation-induced hypoxia. The Ventubation System includes the SupraVent, a unique supraglottic airway which establishes and maintains the airway while providing a dedicated conduit for endotracheal intubation, eliminating the need for a rigid laryngoscope and allowing for continuous ventilation during intubation. The IntroGard® introducer securely couples to the standard endotracheal tube and is anatomically designed to guide it into the trachea with smooth, atraumatic advancement, supporting first-pass success for providers.
“Airway management is often one of the most high-stakes moments in clinical care, yet the tools we rely on have been static for 60 years,” said Glenn Gardner, MD, Founder and President of Gardner Medical Instruments. “The Ventubation airway management platform was built from a clear necessity: to take the risk and stress out of airway management by maintaining continuous ventilation during intubation. With FDA Class I registration, we are able to bring confidence and control to providers in every setting, transforming a historically tense procedure into a safer, more controlled process supporting first-pass success.”
About Gardner Medical Instruments
Gardner Medical Instruments, LLC is committed to developing technologies that simplify airway management by providing continuous ventilation and reducing the risks of hypoxia and airway injury. We are committed to designing procedures and tools that improve patient safety and enhance clinical confidence – because every second counts.
