Cleared Traditional

K261912 - SnØreNegatØr

K261912 is an FDA 510(k) clearance for SnØreNegatØr, manufactured by DnB Innovations, LLC. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K261912 · DnB Innovations, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
53d
Days
Class 2
Risk

K261912 is an FDA 510(k) clearance for the SnØreNegatØr. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by DnB Innovations, LLC (Keller, US). The FDA issued a Cleared decision on July 31, 2026 after a review of 53 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all DnB Innovations, LLC devices

FDA 510(k) Submission Details - K261912

510(k) Number K261912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2026
Decision Date July 31, 2026
Days to Decision 53 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
74d faster than avg
Panel avg: 127d · This submission: 53d
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 K261912.
Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)
K262104 · Ram.Shaw Pte. , Ltd. · Aug 2026
Virtus
K261366 · Somnomed, Inc. · Jun 2026
Snorbliss® Anti-Snoring Device
K261251 · Endeavor Commerce, LLC · Jun 2026
Dormiva Anti-Snoring Mouth Guard
K261134 · Koncept Innovators, Inc. · May 2026
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