Cleared Abbreviated

K121344 - NU SLEEP

K121344 is an FDA 510(k) clearance for NU SLEEP, manufactured by Rh Associates, LLC. The device is a Class 2 Dental device with product code LRK cleared through the Abbreviated 510(k) pathway after a 166-day FDA review.

K121344 · Rh Associates, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
166d
Days
Class 2
Risk

K121344 is an FDA 510(k) clearance for the NU SLEEP. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Rh Associates, LLC (Woodland Hills, US). The FDA issued a Cleared decision on October 17, 2012 after a review of 166 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Rh Associates, LLC devices

FDA 510(k) Submission Details - K121344

510(k) Number K121344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2012
Decision Date October 17, 2012
Days to Decision 166 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 127d · This submission: 166d
Pathway characteristics
Standards-based clearance path.

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 K121344.
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K120372 · Always More Marketing, Inc. · Jun 2012