Cleared Traditional

K090398 - PROVENT PROFESSIONAL SLEEP APNEA THERAPY (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K090398 · Ventus Medical, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
45d
Days
Class 2
Risk

K090398 is an FDA 510(k) clearance for the PROVENT PROFESSIONAL SLEEP APNEA THERAPY. Classified as Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea (product code OHP), Class II - Special Controls.

Submitted by Ventus Medical, Inc. (Belmont, US). The FDA issued a Cleared decision on April 3, 2009 after a review of 45 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 Ventus Medical, Inc. devices

Submission Details

510(k) Number K090398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2009
Decision Date April 03, 2009
Days to Decision 45 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
82d faster than avg
Panel avg: 127d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OHP Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5570
Definition Intranasal Device That Creates Expiratory Resistance For The Treatment Of Obstructive Sleep Apnea.
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.