FDA Product Code PLC: Sleep Appliances With Patient Monitoring
For The Treatment Of Night Time Snoring And Mild To Moderate Obstructive Sleep Apnea In Patients 18 Years Of Age Or Older While Also Measuring Patient Compliance To Oral Appliance Therapy.
Leading manufacturers include Somnomed, Inc. and Prosomnus Sleep Technologies.
FDA 510(k) Cleared Sleep Appliances With Patient Monitoring Devices (Product Code PLC)
About Product Code PLC - Regulatory Context
510(k) Submission Activity
9 total 510(k) submissions under product code PLC since 2015, with 9 receiving FDA clearance (average review time: 230 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under PLC have taken an average of 279 days to reach a decision - up from 216 days historically. Manufacturers should account for longer review timelines in current project planning.
PLC devices are reviewed by the Dental panel. Browse all Dental devices →