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FDA 510(k)

SleepRight Snore Aid

K-Number: K250122 · 2025-05-19

ApplicantSplintek, Inc.
Decision Date2025-05-19
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SleepRight Snore Aid is a medical device manufactured by Splintek, Inc.. It received FDA 510(k) clearance on 2025-05-19 under approval number K250122. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SleepRight Snore Aid?

SleepRight Snore Aid is a medical device that received FDA 510(k) clearance on 2025-05-19. It is manufactured by Splintek, Inc.. The 510(k) number is K250122.

When was SleepRight Snore Aid approved by the FDA?

SleepRight Snore Aid received FDA 510(k) clearance on 2025-05-19, under approval number K250122.

What company makes SleepRight Snore Aid?

SleepRight Snore Aid is manufactured by Splintek, Inc..

What is the FDA product code for SleepRight Snore Aid?

The FDA product code for SleepRight Snore Aid is LRK.

Other Devices by Splintek, Inc.

K172223SleepRight ProRx Custom Dental Guard K193577SleepRight ProRx Custom Dental Guard K212767SleepRight Select-Comfort Dental Guard K212706SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard

Related Devices (Code: LRK)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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