Cleared Traditional

K113022 - PURESLEEP (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K113022 · Sleep Science Partners, Inc. · Dental device
Jun 2012
Decision
244d
Days
Class 2
Risk

K113022 is an FDA 510(k) clearance for the PURESLEEP. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Sleep Science Partners, Inc. (Larkspur, US). The FDA issued a Cleared decision on June 11, 2012 after a review of 244 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.

Submission Details

510(k) Number K113022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2011
Decision Date June 11, 2012
Days to Decision 244 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 158d · This submission: 244d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 19
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K113022.
Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)
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QuietLab Pro
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Hushd Avera
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