BEUDAMED
    Product Code: OHP FDA class 2 21 CFR 872.5570

    Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea

    Dental

    The Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea is an intranasal device placed over the nostrils that creates resistance during exhalation, thereby increasing end-expiratory pressure in the airway to reduce upper airway collapse associated with obstructive sleep apnea. Classified as FDA Class 2 under regulation 21 CFR 872.5570 within the Dental medical specialty, it requires a 510(k) premarket notification and is eligible for third-party review. The product code is OHP. It is not flagged as an implant or life-sustaining device.

    View on FDA
    510(k)s
    5
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    3
    Years Active
    12

    Research product code OHP in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    OHP
    Device Class
    FDA class 2
    Regulation Number
    872.5570
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    Definition

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

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 5 510(k) clearances via K numbers.

    K Number Device Name
    K191728 ULTepap Expiratory Positive Airway Pressure (EPAP) Device
    K180619 Bongo
    K102404 PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50)
    K090398 PROVENT PROFESSIONAL SLEEP APNEA THERAPY
    K071560 PROVENT NASAL DILATOR, MODEL BR2

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.