Cleared Traditional

K250122 - SleepRight Snore Aid (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250122 · Splintek, Inc. · Dental device
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Optimized for regulatory review, auditing and printing
May 2025
Decision
122d
Days
Class 2
Risk

K250122 is an FDA 510(k) clearance for the SleepRight Snore Aid. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Splintek, Inc. (Lenexa, US). The FDA issued a Cleared decision on May 19, 2025 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5570 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Splintek, Inc. devices

Submission Details

510(k) Number K250122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2025
Decision Date May 19, 2025
Days to Decision 122 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 127d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LRK Device, Anti-snoring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5570
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - LRK Device, Anti-snoring

All 209
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K250122.
ShaeferH
K252942 · Shaeferh, LLC · Apr 2026
Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)
K253845 · Ram.Shaw Pte. , Ltd. · Mar 2026
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Park Dental Nylon MAD
K252976 · Park Dental Research Corp. · Dec 2025
QuietLab Pro
K253868 · QuietLab, LLC · Dec 2025
Hushd Avera
K252161 · Good Sleep CO Pte , Ltd. · Nov 2025