Cleared Abbreviated

K111207 - RESPIRE BLUE SERIES

K111207 is an FDA 510(k) clearance for RESPIRE BLUE SERIES, manufactured by Respire Medical. The device is a Class 2 Dental device with product code LRK cleared through the Abbreviated 510(k) pathway after a 116-day FDA review.

K111207 · Respire Medical · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
116d
Days
Class 2
Risk

K111207 is an FDA 510(k) clearance for the RESPIRE BLUE SERIES. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Respire Medical (Woodland Hills, US). The FDA issued a Cleared decision on August 23, 2011 after a review of 116 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K111207

510(k) Number K111207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2011
Decision Date August 23, 2011
Days to Decision 116 days
Submission Type Abbreviated
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
12d faster than avg
Panel avg: 128d · This submission: 116d
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 213
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K111207.
PILLAR PALATAL IMPLANT SYSTEM
K110623 · Medtronic Xomed, Inc. · Feb 2012
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K112205 · Consumer Health Products, Inc. · Nov 2011
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
K111207 · RESPIRE BLUE SERIES
Download PDF FDA Summary Respire Medical