Cleared Traditional

K102404 - PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80)

Also marketed or referenced as:
PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50)

K102404 is an FDA 510(k) clearance for PROVENT PROFESSIONAL SLEEP APNEA THERAP..., manufactured by Ventus Medical, Inc.. The device is a Class 2 Dental device with product code OHP cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K102404 · Ventus Medical, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
100d
Days
Class 2
Risk

K102404 is an FDA 510(k) clearance for the PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80). 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 December 2, 2010 after a review of 100 days - within the typical 510(k) review window.

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 - K102404

510(k) Number K102404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2010
Decision Date December 02, 2010
Days to Decision 100 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
28d faster than avg
Panel avg: 128d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OHP Device Classification - Class 2, Special Controls

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.

Regulatory Peers - OHP Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea

Devices cleared under the same product code (OHP) and FDA review panel - the closest regulatory comparables to K102404.
ULTepap Expiratory Positive Airway Pressure (EPAP) Device
K191728 · Bryggs Medical, LLC · Feb 2020
Bongo
K180619 · Innomed Healthscience, Inc. · Aug 2018
PROVENT PROFESSIONAL SLEEP APNEA THERAPY
K090398 · Ventus Medical, Inc. · Apr 2009
PROVENT NASAL DILATOR, MODEL BR2
K071560 · Ventus Medical, Inc. · Feb 2008