Cleared Abbreviated

K030440 - OASYS-ORAL AIRWAY SYSTEM (FDA 510(k) Clearance)

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K030440 · Mark Abramson, D.D.S., Inc. · Dental device
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.

Submission Details

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
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 158d · This submission: 196d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 19
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