Cleared Traditional

K991209 - ORAL SLEEP DISORDER AID

K991209 is an FDA 510(k) clearance for ORAL SLEEP DISORDER AID, manufactured by Perl-Rad Sleep Disorder Lab. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K991209 · Perl-Rad Sleep Disorder Lab · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
166d
Days
Class 2
Risk

K991209 is an FDA 510(k) clearance for the ORAL SLEEP DISORDER AID. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Perl-Rad Sleep Disorder Lab (Carmel, US). The FDA issued a Cleared decision on September 22, 1999 after a review of 166 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 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 - K991209

510(k) Number K991209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1999
Decision Date September 22, 1999
Days to Decision 166 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
38d slower than avg
Panel avg: 128d · This submission: 166d
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 K991209.
NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE
K013049 · Dennis R. Bailey, Dds · Nov 2001
THE QUIET SLEEPER
K012142 · Precision Dental Laboratories, Inc. · Oct 2001
TONGUE STABILIZER DEVICE
K993381 · University of Otago · Dec 1999
DR. B'S MOUTHPIECE, MODEL 32129-10002
K991948 · Snore - Ezzer · Sep 1999
REPOSE BONE SCREW SYSTEM
K981677 · Influence, Inc. · Aug 1999
SNORE-AID PLUS
K991449 · Dental Imagineers, LLC · Jul 1999
K991209 · ORAL SLEEP DISORDER AID
Download PDF FDA Summary Perl-Rad Sleep Disord…