Cleared Traditional

K131138 - RESPIRE PINK SERIES - HERBST

K131138 is an FDA 510(k) clearance for RESPIRE PINK SERIES - HERBST, manufactured by Respire Medical. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K131138 · Respire Medical · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2013
Decision
139d
Days
Class 2
Risk

K131138 is an FDA 510(k) clearance for the RESPIRE PINK SERIES - HERBST. 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 September 9, 2013 after a review of 139 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 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.

FDA 510(k) Submission Details - K131138

510(k) Number K131138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2013
Decision Date September 09, 2013
Days to Decision 139 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
11d slower than avg
Panel avg: 128d · This submission: 139d
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 214
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K131138.
THE MOSES ELITE APPLIANCE
K132933 · Allen J. Moses, Dds, Ltd. · Apr 2014
LUCO HYBRID OSA APPLIANCE
K130797 · Luco Hybrid Osa Appliance, Inc. · Dec 2013
ASA ORAL APPLIANCES
K130504 · American Sleep Association · Oct 2013
ACRYLIC HERBST APPLIANCE
K113126 · Gergens Orthodontic Lab · Jul 2013
SOMNODENT HERBST
K130558 · Somnomed, Inc. · May 2013
HEALTHY SLEEP APPLIANCE
K123410 · Healthy Sleep Dental Laboratory · Apr 2013
K131138 · RESPIRE PINK SERIES - HERBST
Download PDF FDA Summary Respire Medical