FDA Product Code LRK: Device, Anti-snoring
Oral appliance therapy provides an effective non-CPAP option for snoring and mild obstructive sleep apnea. FDA product code LRK covers anti-snoring devices worn in the mouth during sleep.
These mandibular advancement or tongue retention devices reposition the jaw or tongue to maintain airway patency during sleep, reducing snoring and apnea events. They are custom-fabricated or thermoplastic appliances worn during sleep.
LRK devices are Class II medical devices, regulated under 21 CFR 872.5570 and reviewed by the FDA Dental panel.
Leading manufacturers include Prismatik Dentalcraft, Inc., Good Sleep CO Pte , Ltd. and Fissiontech, LLC.
FDA 510(k) Cleared Device, Anti-snoring Devices (Product Code LRK)
About Product Code LRK - Regulatory Context
510(k) Submission Activity
210 total 510(k) submissions under product code LRK since 1988, with 210 receiving FDA clearance (average review time: 175 days).
Submission volume has remained relatively stable over the observed period, with 18 submissions in the last 24 months.
FDA Review Time
Recent submissions under LRK have taken an average of 138 days to reach a decision - down from 178 days historically, suggesting improved FDA processing for this classification.
LRK devices are reviewed by the Dental panel. Browse all Dental devices →