Cleared Traditional

K042161 - ANTI-SNORING/SLEEP APNEA DEVICE

K042161 is an FDA 510(k) clearance for ANTI-SNORING/SLEEP APNEA DEVICE, manufactured by Rj & VK Bird Pty , Ltd.. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K042161 · Rj & VK Bird Pty , Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
78d
Days
Class 2
Risk

K042161 is an FDA 510(k) clearance for the ANTI-SNORING/SLEEP APNEA DEVICE. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Rj & VK Bird Pty , Ltd. (Middle Park, Victoria, AU). The FDA issued a Cleared decision on October 27, 2004 after a review of 78 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.

View all Rj & VK Bird Pty , Ltd. devices

FDA 510(k) Submission Details - K042161

510(k) Number K042161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2004
Decision Date October 27, 2004
Days to Decision 78 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 127d · This submission: 78d
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 131
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K042161.
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RESPIRONICS CUSTOM I ORAL APPLIANCE
K033822 · Respironics, Inc. · Feb 2004
RESPIRONICS CUSTOM II ORAL APPLIANCE
K033823 · Respironics, Inc. · Feb 2004
TONGUE STABILIZER DEVICE
K993381 · University of Otago · Dec 1999