Cleared Traditional

K071560 - PROVENT NASAL DILATOR, MODEL BR2 (FDA 510(k) Clearance)

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

K071560 · Ventus Medical, Inc. · Dental device
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Feb 2008
Decision
246d
Days
Class 2
Risk

K071560 is an FDA 510(k) clearance for the PROVENT NASAL DILATOR, MODEL BR2. Classified as Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea (product code OHP), Class II - Special Controls.

Submitted by Ventus Medical, Inc. (Hillsborough, US). The FDA issued a Cleared decision on February 8, 2008 after a review of 246 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.

View all Ventus Medical, Inc. devices

Submission Details

510(k) Number K071560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2007
Decision Date February 08, 2008
Days to Decision 246 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
119d slower than avg
Panel avg: 127d · This submission: 246d
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.