Cleared Traditional

K252942 - ShaeferH

K252942 is an FDA 510(k) clearance for ShaeferH, manufactured by Shaeferh, LLC. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K252942 · Shaeferh, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2026
Decision
207d
Days
Class 2
Risk

K252942 is an FDA 510(k) clearance for the ShaeferH. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Shaeferh, LLC (Boston, US). The FDA issued a Cleared decision on April 10, 2026 after a review of 207 days - an extended review cycle.

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 Shaeferh, LLC devices

FDA 510(k) Submission Details - K252942

510(k) Number K252942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2025
Decision Date April 10, 2026
Days to Decision 207 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
80d slower than avg
Panel avg: 127d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRK Device Classification - Class 2, Special Controls

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 167
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K252942.
Virtus
K261366 · Somnomed, Inc. · Jun 2026
Snorbliss® Anti-Snoring Device
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Dormiva Anti-Snoring Mouth Guard
K261134 · Koncept Innovators, Inc. · May 2026
Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)
K253845 · Ram.Shaw Pte. , Ltd. · Mar 2026
Myosa (S1H, S1, S2, S3, S1M, S2M)
K252531 · Myofunctional Research Co. · Mar 2026
Park Dental Nylon MAD
K252976 · Park Dental Research Corp. · Dec 2025