Cleared Traditional

K100185 - SLEEP APP

K100185 is an FDA 510(k) clearance for SLEEP APP, manufactured by Sleep Medicine Network, Inc.. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K100185 · Sleep Medicine Network, Inc. · Dental device
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Nov 2010
Decision
301d
Days
Class 2
Risk

K100185 is an FDA 510(k) clearance for the SLEEP APP. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Sleep Medicine Network, Inc. (Portland, US). The FDA issued a Cleared decision on November 19, 2010 after a review of 301 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.

View all Sleep Medicine Network, Inc. devices

FDA 510(k) Submission Details - K100185

510(k) Number K100185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2010
Decision Date November 19, 2010
Days to Decision 301 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
174d slower than avg
Panel avg: 127d · This submission: 301d
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 98
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