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Therapeutic devices · 21 CFR 872 Subpart F

Intranasal Expiratory Resistance Valve for Obstructive Sleep Apnea

Intranasal device that creates expiratory resistance for the treatment of obstructive sleep apnea.

FDA codeOHPClass221 CFR872.5570Pathway510(k)
Companies listing it
33 makers
Brands and models
3
510(k) clearances
50 in five years
FDA name
Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea
2008: 12009: 12010: 12018: 12020: 119801990200020102020

510(k) clearances per year, 1976–2026

Companies that list OHP

3 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Innomed Healthscience, Inc.United StatesMakerBongo RX12018
Molded Rubber and Plastic, LLCUnited StatesMakerBongo RX——
ValensilUnited StatesMakerULTepap——

510(k) clearances

Decided510(k)DeviceApplicant
21 Feb 2020K191728ULTepap Expiratory Positive Airway Pressure (EPAP) DeviceBryggs Medical, LLC
16 Aug 2018K180619BongoInnomed Healthscience, Inc.
2 Dec 2010K102404PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50)Ventus Medical, Inc.
3 Apr 2009K090398PROVENT PROFESSIONAL SLEEP APNEA THERAPYVentus Medical, Inc.
8 Feb 2008K071560PROVENT NASAL DILATOR, MODEL BR2Ventus Medical, Inc.

Official records: FDA product classification for OHP · 21 CFR 872.5570.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026