Cleared Special

K033823 - RESPIRONICS CUSTOM II ORAL APPLIANCE

K033823 is an FDA 510(k) clearance for RESPIRONICS CUSTOM II ORAL APPLIANCE, manufactured by Respironics, Inc.. The device is a Class 2 Dental device with product code LRK cleared through the Special 510(k) pathway after a 58-day FDA review.

K033823 · Respironics, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
58d
Days
Class 2
Risk

K033823 is an FDA 510(k) clearance for the RESPIRONICS CUSTOM II ORAL APPLIANCE. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on February 6, 2004 after a review of 58 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K033823

510(k) Number K033823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2003
Decision Date February 06, 2004
Days to Decision 58 days
Submission Type Special
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
70d faster than avg
Panel avg: 128d · This submission: 58d
Pathway characteristics
Modification to existing cleared device.

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 K033823.
PILLAR PALATAL IMPLANT SYSTEM
K040417 · Restore Medical, Inc. · Jul 2004
RESTFUL NIGHTS, IST-APPLIANCE
K021569 · Ottawa Dental Laboratory · Mar 2004
RESPIRONICS CUSTOM I ORAL APPLIANCE
K033822 · Respironics, Inc. · Feb 2004
OASYS-ORAL AIRWAY SYSTEM
K030440 · Mark Abramson, D.D.S., Inc. · Aug 2003
THE SUAD DEVICE
K023836 · Strong Dental, Inc. · Jul 2003
THE BREATHE EZ ANTI-SNORING DEVICE
K022891 · D&S Redhage · Feb 2003
K033823 · RESPIRONICS CUSTOM II ORAL APPLIANCE
Download PDF FDA Summary Respironics, Inc.