Cleared Traditional

K113022 - PURESLEEP

K113022 is an FDA 510(k) clearance for PURESLEEP, manufactured by Sleep Science Partners, Inc.. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K113022 · Sleep Science Partners, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Sleep Science Partners, Inc. devices

FDA 510(k) Submission Details - K113022

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 127d · This submission: 244d
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 K113022.
SOMNOGUARD SP SOFT
K121761 · Tomed Dr. Toussaint GmbH · Sep 2012
DR GREENBURGS HYBRID ACRYLIC
K120371 · Always More Marketing, Inc. · Jun 2012
DR GREENBURGS HYBRID VACUUM
K120372 · Always More Marketing, Inc. · Jun 2012
SOMNODENT G2
K121340 · Somnomed, Inc. · May 2012
REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP
K103704 · Zephyr Sleep Technologies, Inc. · Mar 2012
APNEARX
K113569 · Apnea Science Corporation · Mar 2012