FDA Product Code BTT: Humidifier, Respiratory Gas, (direct Patient Interface)
Delivering humidified gas to mechanically ventilated patients prevents airway desiccation and protects mucosal integrity. FDA product code BTT covers direct patient interface respiratory gas humidifiers.
These devices add heat and moisture to inspired gases delivered through ventilator circuits or oxygen therapy systems, maintaining physiological humidity levels in the airways. They are essential in neonatal intensive care and long-term ventilator-dependent patients.
BTT devices are Class II medical devices, regulated under 21 CFR 868.5450 and reviewed by the FDA Anesthesiology panel.
Leading manufacturers include Fisher &Paykel Healthcare , Ltd., Medline Industries, LP and Medline Industries, Inc..
List of Humidifier, Respiratory Gas, (direct Patient Interface) devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Humidifier, Respiratory Gas, (direct Patient Interface) devices (product code BTT). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Anesthesiology FDA review panel. Browse all Anesthesiology devices →