Hans Rudolph 7500 Series Reusable Oro-Nasal NIV Masks
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K030515 FDA 510(k)
- FDA Product Code
- CBK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5895 FDA 510(k)
- Regulation Number
- 868.5895 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Hans Rudolph 7500 Series Reusable Oro-Nasal NIV Masks are designed as a patient interface for noninvasive ventilation (NIV), providing continuous respiratory support via a full-face seal over the nose and mouth. These masks are classified as ventilators and are intended for facility use, delivering controlled airflow to patients requiring respiratory assistance without invasive intubation.
These reusable masks are supplied with silicone rubber face components and polycarbonate swivel ports (straight or elbow type) and headgear, available in five sizes. They are intended for multi-patient use and must be cleaned and disinfected between applications. The device is authorized under FDA 510K and MDR regulations, adhering to Class II medical device standards for ventilator accessories. No MRI safety information is specified.
Frequently asked questions
Are these masks designed for single-use or can they be reused between patients?
The Hans Rudolph 7500 Series Oro-Nasal NIV Masks are explicitly designed for multi-patient reuse. They must be cleaned and disinfected thoroughly between uses to ensure patient safety and device integrity. This reusable classification is critical for facility-based use where infection control protocols are strictly followed.
What materials are the face components and ports made of, and how does this affect their cleaning process?
The face components are made of silicone rubber, while the swivel ports (available in straight or elbow types) are constructed from polycarbonate. Silicone is durable and resistant to many disinfectants, making it suitable for repeated cleaning and sterilization processes. Polycarbonate ports are also designed to withstand frequent disinfection, though manufacturers typically recommend following the supplier’s guidelines for cleaning agents and methods to avoid material degradation.
How many sizes are available for the 7500 Series, and what determines the appropriate size for a patient?
The 7500 Series is available in five sizes, which are tailored to accommodate a range of patient anatomies for a secure, comfortable seal. The correct size is determined by measuring the patient’s facial dimensions (e.g., nose-to-mouth distance and cheek width) and matching them to the manufacturer’s sizing chart. Proper sizing ensures effective ventilation and minimizes leaks, which is critical for noninvasive ventilation.
What type of regulatory approvals do these masks hold, and what does that mean for their use in clinical settings?
The Hans Rudolph 7500 Series Reusable Oro-Nasal NIV Masks are authorized under FDA 510K clearance and MDR (Medical Device Regulation) standards. This means they meet regulatory requirements for safety and performance as ventilator accessories, specifically for facility-based use. The approvals confirm compliance with Class II medical device standards, ensuring they can be used in clinical settings where noninvasive ventilation is administered.
Are there any special storage requirements for these reusable masks to maintain their functionality and sterility?
While the device data does not specify explicit sterility requirements for storage, reusable medical devices like these masks should be stored in a clean, dry environment to prevent contamination or damage. After cleaning and disinfection, they should be kept in a sealed, protective case or packaging to maintain hygiene until the next use. Always follow the manufacturer’s instructions for storage to preserve material integrity and ensure readiness for disinfection.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Hans Rudolph Reusable Vented Full Face V2 Mask - Taleb Medical, Face Mask (NIV) Non-Invasive Ventilation Reusable & Disposable, Hans Rudolph - TradeMed
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K030515 | Class II | Active |
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Manufacturer
- Manufacturer
- Hans Rudolph, Inc.
Sources (2)
- FDA 510(k) K030515 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026