Cleared Abbreviated

K102463 - GOOD NIGHT

K102463 is an FDA 510(k) clearance for GOOD NIGHT, manufactured by Larry V Connell, Dmd. The device is a Class 2 Dental device with product code LRK cleared through the Abbreviated 510(k) pathway after a 268-day FDA review.

K102463 · Larry V Connell, Dmd · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
268d
Days
Class 2
Risk

K102463 is an FDA 510(k) clearance for the GOOD NIGHT. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Larry V Connell, Dmd (Yakima, US). The FDA issued a Cleared decision on May 25, 2011 after a review of 268 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 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 - K102463

510(k) Number K102463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2010
Decision Date May 25, 2011
Days to Decision 268 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
140d slower than avg
Panel avg: 128d · This submission: 268d
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
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K102463 · GOOD NIGHT
Download PDF FDA Summary Larry V Connell, Dmd