Cleared Traditional

K101155 - AURADORM (NEUROMUSCULAR SLEEP)

K101155 is an FDA 510(k) clearance for AURADORM (NEUROMUSCULAR SLEEP), manufactured by Sleepwright. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 381-day FDA review.

K101155 · Sleepwright · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
381d
Days
Class 2
Risk

K101155 is an FDA 510(k) clearance for the AURADORM (NEUROMUSCULAR SLEEP). Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Sleepwright (Santa Fe, US). The FDA issued a Cleared decision on May 12, 2011 after a review of 381 days - an unusually long review period, suggesting complex equivalence evaluation.

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

FDA 510(k) Submission Details - K101155

510(k) Number K101155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2010
Decision Date May 12, 2011
Days to Decision 381 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
253d slower than avg
Panel avg: 128d · This submission: 381d
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 213
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K101155.
ACRYLIC HERBST APPLIANCE
K111009 · Embassy Dental Laboratory · Jul 2011
APNEA GUARD
K111110 · Advanced Brain Monitoring, Inc. · Jul 2011
GOOD NIGHT
K102463 · Larry V Connell, Dmd · May 2011
PANTINO PRO POSITINER
K102521 · Somnomed, Inc. · Mar 2011
SNORE GUARD
K103004 · Ranir, LLC · Feb 2011
DYNAFLEX
K103076 · Dyna Flex · Feb 2011
K101155 · AURADORM (NEUROMUSCULAR SLEEP)
Download PDF FDA Summary Sleepwright