FDA Product Code BTY: Calculator, Predicted Values, Pulmonary Function
Leading manufacturers include Eresearchtechnology GmbH, Vitalograph (Ireland) , Ltd. and Virtus Technology Aps.
FDA 510(k) Cleared Calculator, Predicted Values, Pulmonary Function Devices (Product Code BTY)
About Product Code BTY - Regulatory Context
510(k) Submission Activity
63 total 510(k) submissions under product code BTY since 1978, with 63 receiving FDA clearance (average review time: 158 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 3 in the prior period.
FDA Review Time
Recent submissions under BTY have taken an average of 285 days to reach a decision - up from 154 days historically. Manufacturers should account for longer review timelines in current project planning.
BTY devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →