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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 the device name listed in this FDA 510(k) record. The listed applicant is Splintek, Inc.. It received FDA 510(k) clearance on 2025-05-19 under 510(k) 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. The listed applicant is Splintek, Inc.. The 510(k) number is K250122.

When did SleepRight Snore Aid receive FDA 510(k) clearance?

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

Who is the listed applicant for SleepRight Snore Aid?

The FDA 510(k) record lists Splintek, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SleepRight Snore Aid?

The FDA product code for SleepRight Snore Aid is LRK.

Other records listing Splintek, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: LRK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261912SnØreNegatØrDnB Innovations, LLCK261366VirtusSomnomed, Inc.K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLCK261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.K252942ShaeferHShaeferh, LLCK253845Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)Ram.Shaw Pte. , Ltd.

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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