FDA Product Code BWF: Spirometer, Therapeutic (incentive)
Leading manufacturers include Medline Industries, Inc., Enchant Tek Co. , Ltd. and Tidal Medical Technologies, LLC.
FDA 510(k) Cleared Spirometer, Therapeutic (incentive) Devices (Product Code BWF)
About Product Code BWF - Regulatory Context
510(k) Submission Activity
108 total 510(k) submissions under product code BWF since 1976, with 108 receiving FDA clearance (average review time: 121 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 4 in the prior period.
FDA Review Time
Recent submissions under BWF have taken an average of 482 days to reach a decision - up from 118 days historically. Manufacturers should account for longer review timelines in current project planning.
BWF devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →