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 Laboratorios Biogalenic S.A. DE C.V..
FDA 510(k) Cleared Humidifier, Respiratory Gas, (direct Patient Interface) Devices (Product Code BTT)
About Product Code BTT - Regulatory Context
510(k) Submission Activity
221 total 510(k) submissions under product code BTT since 1976, with 221 receiving FDA clearance (average review time: 151 days).
Submission volume has remained relatively stable over the observed period, with 12 submissions in the last 24 months.
FDA Review Time
FDA review times for BTT submissions have been consistent, averaging 172 days recently vs 150 days historically.
BTT devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →