Cleared Abbreviated

K030440 - OASYS-ORAL AIRWAY SYSTEM

K030440 is an FDA 510(k) clearance for OASYS-ORAL AIRWAY SYSTEM, manufactured by Mark Abramson, D.D.S., Inc.. The device is a Class 2 Dental device with product code LRK cleared through the Abbreviated 510(k) pathway after a 196-day FDA review.

K030440 · Mark Abramson, D.D.S., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
196d
Days
Class 2
Risk

K030440 is an FDA 510(k) clearance for the OASYS-ORAL AIRWAY SYSTEM. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Mark Abramson, D.D.S., Inc. (Redwood City, US). The FDA issued a Cleared decision on August 26, 2003 after a review of 196 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.

View all Mark Abramson, D.D.S., Inc. devices

FDA 510(k) Submission Details - K030440

510(k) Number K030440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2003
Decision Date August 26, 2003
Days to Decision 196 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 127d · This submission: 196d
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 86
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K030440.
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RESPIRONICS CUSTOM I ORAL APPLIANCE
K033822 · Respironics, Inc. · Feb 2004
RESPIRONICS CUSTOM II ORAL APPLIANCE
K033823 · Respironics, Inc. · Feb 2004
TAP
K964516 · Nellcor Puritan Bennett, Inc. · Jan 1997
TAP ANTI-SNORING DEVICE
K962516 · Nellcor Puritan Bennett, Inc. · Sep 1996
ORTHODONTIC BITE
K922984 · American Orthodontics · Mar 1993