FDA Product Code SFK: Respiratory Effort Belt For Polysomnography
To Assess Respiratory/breathing Effort By Measuring The Movement Of Chest And Abdominal Walls. The Belts Function As Accessories To Sleep/polysomnography (psg) And Home Sleep Apnea Test (hsat) Systems.
Leading manufacturers include Neurotronics, LLC.
FDA 510(k) Cleared Respiratory Effort Belt For Polysomnography Devices (Product Code SFK)
About Product Code SFK - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SFK since 2025, with 1 receiving FDA clearance (average review time: 108 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
SFK devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →