Cleared Traditional

K262937 - PDR Airway Device

K262937 is an FDA 510(k) clearance for PDR Airway Device, manufactured by Park Dental Research Corp.. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K262937 · Park Dental Research Corp. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
60d
Days
Class 2
Risk

K262937 is an FDA 510(k) clearance for the PDR Airway Device. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Park Dental Research Corp. (Ardmore, US). The FDA issued a Cleared decision on October 20, 2026 after a review of 60 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K262937

510(k) Number K262937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2026
Decision Date October 20, 2026
Days to Decision 60 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
68d faster than avg
Panel avg: 128d · This submission: 60d
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 216
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K262937.
Forza
K260136 · True Function Laboratory, Inc. · Oct 2026
Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)
K262104 · Ram.Shaw Pte. , Ltd. · Aug 2026
SnØreNegatØr
K261912 · DnB Innovations, LLC · Jul 2026
Virtus
K261366 · Somnomed, Inc. · Jun 2026
Snorbliss® Anti-Snoring Device
K261251 · Endeavor Commerce, LLC · Jun 2026
Dormiva Anti-Snoring Mouth Guard
K261134 · Koncept Innovators, Inc. · May 2026
K262937 · PDR Airway Device
Download PDF FDA Summary Park Dental Research …